You are on page 1of 365

CDC

INFECTIOUS DISEASES
LABORATORY TEST
DIRECTORY

December 2016, Version 7.0


This document was created under National Center for Emerging and Zoonotic Diseases/ Office of
Infectious Diseases (NCEZID/OD). The printed version of CDC's Infectious Diseases Laboratory Test
Directory contains information that is current as of December 9, 2016. All information contained
herein is subject to change.

For the most current test information, please view the 508 compliant version of the CDC's
Infectious Diseases Laboratory Test Directory on: http://www.cdc.gov/laboratory/specimen-
submission/list.html.
Test Order
Acanthamoeba Molecular Detection
CDC-10471

Synonym(s) Free-living ameba, parasite


Pre-Approval Needed None
Supplemental Information Please provide the following information: history of present illness, exposure
Required history, past medical history, treatment history, CSF results, imaging results. If
images are available please upload to: http://www.cdc.gov/dpdx
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen For Acanthamoeba and Balamuthia molecular detection, tissue is the preferred
Type for Testing specimen type; however, these amebae can occasionally be detected in
cerebrospinal fluid (CSF; see 'Interference & Limitations' below). For Naegleria
fowleri molecular detection, CSF is the preferred specimen type. For suspected
cases of Acanthamoeba Keratitis (AK), we also accept deep corneal scraping,
ocular fluid, and contact lens solution as specimen.
Minimum Volume Required 0.2 g tissue: 1 mL fluids

Storage & Preservation of Storage and preservation is specimen specific


Specimen Prior to Shipping

Transport Medium Small piece of tissue should be transported in small amount of 0.5x PBS to
prevent dryness.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. In addition to two patient identifiers
(sex, date of birth, name, etc.), provide specimen type and date of collection.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Please contact
Include Specimen Handling laboratory prior to shipping any specimen and include "Unit 53" on the outside
Requirements of package. Ship specimen at room temperature, not on dry ice, as an etiologic
agent, unless the specimen has been previously frozen. Frozen specimens may
be shipped in cold with ice-packs. Please send the shipment tracking number on
the day of shipment by e-mail to the CDC Point of Contacts (see below).
Methodology Real-Time PCR
Turnaround Time 7 Days
Interferences & Limitations Formalin-fixed specimens are not suitable for molecular studies as formalin
fixation may cause DNA degradation. Fresh or frozen specimens, if available, are
preferred. Additionally, CSF is NOT the preferred specimen type for
Acanthamoeba or Balamuthia detection, because a negative CSF test result does
not completely rule out infections with these amebae.
Additional lnformation None
CDC Points of Contact Jennifer Cope
(404) 718-4878
bjt9@cdc.gov
Ibne Ali
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 1 of 363


Test Order
Actinomyces Anaerobic ID
CDC-10483

Synonym(s) Anaerobe ID, Bacterial Identification, Anaerobe


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Anaerobic bacteria from clinically relevant sources, pure culture isolate in
Type for Testing suitable anaerobic transport medium (e.g., Chopped Meat Glucose Broth). Prior
approval from laboratory required for other sample/specimen types.
Minimum Volume Required Not Applicable

Storage & Preservation of Store anaerobically


Specimen Prior to Shipping

Transport Medium Pure culture isolate in Chopped Meat Glucose broth, thioglycolate broth or
frozen in TSB plus glycerol
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries, as an
Include Specimen Handling etiologic agent.
Requirements
Frozen specimen should be shipped on dry ice
Specimen stored at room temperature should be shipped at room temperature
Methodology 16s Sequencing, MALDI-TOF, Phenotypic Testing
Turnaround Time 28 Days
Interferences & Limitations Specimens from respiratory, vaginal, and fecal sources are not acceptable
Additional lnformation None
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Kamile Rasheed
(404) 639-3247
jkr1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 2 of 363


Test Order
Actinomycetes-Aerobic -ID
CDC-10148

Synonym(s) Nocardia, Streptomyces


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately.


Specimen Prior to Shipping

Transport Medium Suitable agar slant medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary culture based on specimen type, 16S sequence based identification,
MALDI-TOF
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 3 of 363


Test Order
Actinomycetes-Aerobic -ID and AST
CDC-10149

Synonym(s) Actinos
Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology AST by broth microdilution, Primary Culture based on specimen type, 16S
sequence based identification, MALDI-TOF
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 4 of 363


Test Order
Adenovirus Molecular Detection and Typing
CDC-10170

Synonym(s) None
Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Kamili, Shifaq, (404) 639-2799, sgk5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Upper or lower respiratory tract specimens, eye swabs, stool, serum, blood or
Type for Testing plasma, pure culture isolate
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate all specimens promptly after collection. If specimens can be shipped
Specimen Prior to Shipping to CDC within 72 hours of collection, they should be kept refrigerated at 4C and
shipped on gel ice-packs. Freezing should be avoided if possible, as this will
reduce virus infectivity. Specimens for virus culture should not be frozen at -20
C. If specimens must be held for >72 hours, they should be promptly frozen
at -70C and shipped on dry ice. Liquid specimens should be aliquoted into
properly labeled, leak-proof, unbreakable screw cap vials. Samples should be
collected and processed in a manner that prevents cross-contamination between
specimens, including changing gloves between specimens.
Transport Medium Swabs may be shipped in commercial viral transport media
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 3 Weeks
Interferences & Limitations Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays.
Additional lnformation None
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 5 of 363


Test Order
Alkhurma Identification
CDC-10274

Synonym(s) AHFV
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen, warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 6 of 363


Test Order
Alkhurma Serology
CDC-10285

Synonym(s) AHFV
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 7 of 363


Test Order
Ameba Identification (Acanthamoeba, Balamuthia, Naegleria)
CDC-10286

Synonym(s) Free-living ameba, Acanthamoeba, Balamuthia, Naegleria fowleri


Pre-Approval Needed None
Supplemental Information Please provide the following information: history of present illness, exposure
Required history, past medical history, treatment history, CSF results, imaging results

If images are available please upload to: http://www.cdc.gov/dpdx


Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Fresh, unfixed tissue and Paraffin-embedded and formalin-fixed tissue,
Type for Testing cerebrospinal fluid (CSF), biopsy specimen, deep corneal scrapings, and ocular
fluids
Minimum Volume Required 1 mL fluids; 0.2 g tissue

Storage & Preservation of CSF and fresh, unfixed tissue should be kept at ambient temperatures. Paraffin-
Specimen Prior to Shipping embedded and formalin-fixed tissue should be kept at room temperature. Send
a few H&E-stained slides and a few (about 6) unstained slides for IHC test, or
Paraffin-embedded tissue block.

Unfixed deep scraping and biopsy materials for identification of free-living


amoeba are usually very small and may dry if they are not stored in proper fluid
such as 0.5x PBS or amoeba saline (see composition in the 'Additional
Information'). These specimens should be transported to the laboratory within
24 hours.
Transport Medium Care should be taken to pack glass slides securely, as they can be damaged in
shipment if not packed in a crush-proof container. For deep scraping and biopsy
materials please transport in ameba saline solution, or in 0.5x PBS.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. In addition to two patient identifiers
(sex, date of birth, name, etc.), provide specimen type and date of collection.
Shipping Instructions which Ship Monday-Thursday, overnight. Please contact laboratory prior to shipping
Include Specimen Handling any specimen and include "Unit 53" on the outside of package, and send the
Requirements shipment tracking number on the day of shipment by e-mail to the CDC Point of
Contacts (see below).

Ship all fresh specimens such as CSF, tissue biopsy (e.g., brain, lungs, skin) and
all deep corneal scraping, etc., as an etiologic agent, within 24 hours of
collection. Fresh, unfixed specimens (i.e., CSF and tissue), and formalin-fixed
tissue specimens should be sent at ambient temperature by overnight priority
mail. Please ship these specimens separately from other chilled or frozen
samples being shipped.

If specimen has been previously frozen, please send these specimens by


overnight priority mail on ice-packs.
Methodology Polymerase Chain Reaction (PCR), Indirect Immunofluorescence (IIF),
Immunohistochemical (IHC) staining plus microscopy, Microscopy
Turnaround Time 7 Days
Interferences & Limitations For molecular detection, CSF is the preferred specimen type for N. fowleri only,
and it is NOT the preferred specimen type for Acanthamoeba or Balamuthia

Tuesday, November 29, 2016 Version: 1.4 Page 8 of 363


Test Order
Ameba Identification (Acanthamoeba, Balamuthia, Naegleria)
CDC-10286

detection. A negative CSF test result does not completely rule out infection with
Acanthamoeba or Balamuthia. Fresh or frozen (unfixed) tissue specimens are
preferred for Balamuthia or Acanthamoeba detection. Formalin-fixed specimens
are not suitable for molecular studies as formalin fixation may cause DNA
degradation. Fresh or frozen specimens, if available, are preferred over the
formalin-fixed specimens.
Additional lnformation Include the address of sender and physician contact information with the
specimen.

For deep scraping and biopsy materials please provide the following information
to the laboratorians: patient name (first, last and middle initials), age & date of
birth, sex, date specimen collected, Specimen source (cornea, vitreous fluid),
specimen type (deep scraping, biopsy, vitreous fluid), suspected infection
(keratitis, conjunctivitis, endophthalmitis), transport medium used.

Ameba saline, 1X stock:


Sodium chloride (NaCl) 0.120g
Magnesium sulfate (MgSO4.7HOH) 0.004 g
Sodium phosphate, dibasic (Na2HPO4) 0.142g
Potassium phosphate, monobasic (KH2P O4) 0.136g
Calcium chloride (CaCL2.2HOH) 0.004g
Double distilled water to 1000.0 mL
CDC Points of Contact Jennifer Cope If you are calling outside of regular
(404) 718-4878 business hours, please call the CDC
bjt9@cdc.gov Emergency Operations Center (EOC)
Ibne Ali (770) 488-7100
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 9 of 363


Test Order
Ameba Serology (Acanthamoeba, Balamuthia, Naegleria)
CDC-10287

Synonym(s) Free-living ameba, Acanthamoeba, Balamuthia, Naegleria fowleri


Pre-Approval Needed None
Supplemental Information Please provide the following information: history of present illness, exposure
Required history, past medical history, treatment history, CSF results, imaging results

If images are available please upload to: http://www.cdc.gov/dpdx


Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Sera (two specimen taken 2 weeks apart)


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Serum specimens can be collected from the patient in a red-top tube (plain
Specimen Prior to Shipping vacuum tube with no additive) or a serum-separator tube (tiger top) tube
(red/gray speckled top with gel in the tube). Please centrifuge the specimen, and
if possible, send serum only. If using a plain red-top tube, you must separate the
serum before shipping and send the serum only. Should be kept refrigerated or
frozen.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. In addition to two patient identifiers
(sex, date of birth, name, etc.), provide specimen type and date of collection.
Shipping Instructions which Ship Monday-Thursday, overnight. Please contact laboratory prior to shipping
Include Specimen Handling any specimen and include "Unit 53" on the outside of package.
Requirements
Serum samples should be shipped refrigerated or frozen and packed with cold
packs.
Methodology Indirect Immunofluorescence Antibody (IFA) assay
Turnaround Time 14 Days
Interferences & Limitations The Ameba Serology test has limited diagnostic value for three reasons:
1. This test cannot differentiate between an old infection (or exposure) and an
acute infection.
2. For immunocompromised patients (which is the case for most Acanthamoeba
infections, and some of the Balamuthia infections), there may not be any
antibody response in the infected patients.
3. There may not be enough time to mount an antibody response during an
active N. fowleri (PAM) infection since the time from the onset of infection to
fulminant disease (and death) is usually only 2-8 days.
Additional lnformation Include the address of sender and physician contact information with the
specimen
CDC Points of Contact Jennifer Cope If you are calling outside of regular
(404) 718-4878 business hours, please call the CDC
bjt9@cdc.gov Emergency Operations Center (EOC)
Ibne Ali (770) 488-7100
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 10 of 363


Test Order
Ameba Special Study
CDC-10288

Synonym(s) None
Pre-Approval Needed Cope, Jennifer, (404) 718-4878, bjt9@cdc.gov
Ali, Ibne, (404) 718-4157, xzn5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jennifer Cope If you are calling outside of regular
(404) 718-4878 business hours, please call the CDC
bjt9@cdc.gov Emergency Operations Center (EOC)
Ibne Ali (770) 488-7100
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 11 of 363


Test Order
Anaerobic Bacteria Identification
CDC-10227

Synonym(s) Anaerobe ID, Bacterial Identification, Anaerobe


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Anaerobic bacteria from clinically relevant sources, pure culture isolate in
Type for Testing suitable anaerobic transport medium (e.g., Chopped Meat Glucose Broth). Prior
approval from laboratory required for other sample/specimen types.
Minimum Volume Required Not Applicable

Storage & Preservation of Store anaerobically


Specimen Prior to Shipping

Transport Medium Pure culture isolate in Chopped Meat Glucose broth, thioglycolate broth or
frozen in TSB plus glycerol
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries, as an
Include Specimen Handling etiologic agent.
Requirements
Frozen specimen should be shipped on dry ice
Specimen stored at room temperature should be shipped at room temperature
Methodology 16S Sequencing, MALDI-TOF, Phenotypic Testing
Turnaround Time 28 Days
Interferences & Limitations Specimen from respiratory, vaginal, and fecal sources are not acceptable
Additional lnformation See separate test order for C. difficile
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Kamile Rasheed
(404) 639-3247
jkr1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 12 of 363


Test Order
Anaplasma Molecular Detection
CDC-10290

Synonym(s) Human granulocytic anaplasmosis


Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Acute samples only, anticoagulated whole blood collected in
Type for Testing Ethylenediaminetetraacetic acid (EDTA) treated tubes preferred; serum; fresh
tissue biopsy
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Ethylenediaminetetraacetic acid (EDTA) blood tubes for blood; tissue in a sample
collection tube
Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped refrigerated on cold packs.
Requirements
Methodology Real Time Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 6 Weeks
Interferences & Limitations Hemolysis in whole blood specimen will interfere with results. Multiple freeze
thaw cycles and sample storage above refrigerated temperatures will interfere
with proper nucleic acid extraction. If a specimen is drawn at convalescence it
will reduce the chance of the target organism being present in blood. Avoid
collection of blood specimen in heparin tubes.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 13 of 363


Test Order
Anaplasma Serology
CDC-10292

Synonym(s) Human granulocytic anaplasmosis


Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped refrigerated on cold packs.
Requirements
Methodology Indirect Fluorescence Assay (IFA)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact laboratory prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 14 of 363


Test Order
Anaplasma Special Study
CDC-10291

Synonym(s) Human granulocytic anaplasmosis


Pre-Approval Needed Kato, Cecilia, (404) 639-1075, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Molecular detection, Serology, Culture, Immunohistochemistry (IHC), Other
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 15 of 363


Test Order
Angiostrongylus cantonensis Molecular Detection
CDC-10472

Synonym(s) Angiostrongyliasis, Rat lungworm, parasite


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Cerebrospinal fluid (CSF); tissue


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Storage and preservation is specimen specific


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling on wet ice (cold pack) as an etiologic agent.
Requirements
Methodology Real Time PCR
Turnaround Time 21 Days
Interferences & Limitations Formalin fixed specimens are not suitable for molecular studies
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Theresa Benedict
(404) 718-4124
tgd5@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 16 of 363


Test Order
Antimicrobial Susceptibility Testing - Bacterial
CDC-10223

Synonym(s) AST, Sensitivity, MIC testing


Pre-Approval Needed None
Supplemental Information Confirmation of unusual resistance is required before sending specimen for
Required testing; please specify antibacterial agent of interest and provide previous
results and testing method
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on suitable agar medium


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Keep refrigerated if isolate cannot be shipped immediately. For fastidious
Specimen Prior to Shipping organisms (e.g. Neisseria meningitidis), store at room temperature.

Transport Medium Pure culture isolate on suitable agar medium or frozen in TSB plus glycerol
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday overnight to avoid weekend deliveries, as an
Include Specimen Handling etiologic agent.
Requirements
Refrigerated specimen should be shipped on ice packs
Specimen stored at room temperature should be shipped at room temperature
Methodology Broth Microdilution, Disk Diffusion, Additional Phenotypic Testing, Molecular
detection of resistance markers
Turnaround Time 18 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Kamile Rasheed
(404) 639-3247
JRasheed@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 17 of 363


Test Order
Arbovirus Isolation and Identification
CDC-10281

Synonym(s) Arbo-Isolation, Chikungunya, Zika Virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, cerebrospinal fluid (CSF), and fresh frozen tissue specimen
Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimen should be kept at 4C or colder


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice

Ship to:
Centers for Disease Control & Prevention
3156 Rampart Road (CSU Foothills Campus)
Fort Collins, Colorado 80521
Methodology Isolation in cell culture
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Robert Lanciotti
(970) 221-6440
rsl2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 18 of 363


Test Order
Arbovirus Molecular Detection
CDC-10280

Synonym(s) Arbo-RT-PCR, Chikungunya, Zika Virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, cerebrospinal fluid (CSF), and fresh frozen tissue specimen
Type for Testing
Minimum Volume Required 0.25 mL

Storage & Preservation of Specimen should be kept at 4C or colder


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice

Ship to:
Centers for Disease Control & Prevention
3156 Rampart Road (CSU Foothills Campus)
Fort Collins, Colorado 80521
Methodology RT-Polymerase Chain Reaction (PCR)
Turnaround Time 1 Week
Interferences & Limitations Hemolysis can affect the test results
Additional lnformation None
CDC Points of Contact Robert Lanciotti
(970) 221-6440
rsl2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 19 of 363


Test Order
Arbovirus Neutralization Antibody
CDC-10283

Synonym(s) Arbo-PRNT, Chikungunya, Zika Virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimen should be kept at 4C or colder


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice

Ship to:
Centers for Disease Control & Prevention
3156 Rampart Road (CSU Foothills Campus)
Fort Collins, Colorado 80521
Methodology Plaque reduction neutralization
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Robert Lanciotti
(970) 221-6440
rsl2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 20 of 363


Test Order
Arbovirus Serology
CDC-10282

Synonym(s) Arbo-Serology, Chikungunya, Zika Virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 0.25 mL

Storage & Preservation of Specimen should be kept at 4C or colder


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice

Ship to:
Centers for Disease Control & Prevention
3156 Rampart Road (CSU Foothills Campus)
Fort Collins, Colorado 80521
Methodology ELISA, MIA
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Robert Lanciotti
(970) 221-6440
rsl2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 21 of 363


Test Order
Arbovirus Special Study
CDC-10284

Synonym(s) Zika Virus


Pre-Approval Needed Lanciotti, Robert, (970) 221-6440, rsl2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Robert Lanciotti
(970) 221-6440
rsl2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 22 of 363


Test Order
Arenavirus (New World) - Serology
CDC-10484

Synonym(s) Junin virus, Machupo virus, Guanarito virus, Chapare virus, Sabia virus serology
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood, Serum


Type for Testing
Minimum Volume Required 1.0 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient Name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations None
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 23 of 363


Test Order
Arenavirus (New World) Identification
CDC-10293

Synonym(s) New World Arenavirus, South American hemorrhagic fever viruses


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 24 of 363


Test Order
Arenavirus (Old World) Identification
CDC-10294

Synonym(s) Old World Arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 25 of 363


Test Order
Babesia Molecular Detection
CDC-10473

Synonym(s) Babesiosis; Babesia microti; Babesia duncani, parasite


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Collect a 1-5 ml blood sample in Vacutainer EDTA tubes prior to anti-parasitic
Specimen Prior to Shipping therapy and ship at 4C

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling on wet ice (cold pack) as an etiologic agent.
Requirements
Methodology Conventional PCR, Real Time PCR
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Samaly dos Santos Souza
(404) 718-4786
ynp4@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 26 of 363


Test Order
Babesiosis Serology
CDC-10456

Synonym(s) Babesia microti; Babesia duncani; Babesia divergens, babesiosis, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors (ticks,
Required transfusion); clinical symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and plasma


Type for Testing
Minimum Volume Required 0.5mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Indirect Fluorescent Antibody assay, Antibody detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Hilda Rivera
(404) 718-4100
igi2@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 27 of 363


Test Order
Bacillus anthracis Detection in Clinical Specimens
CDC-10204

Synonym(s) Anthrax PCR


Pre-Approval Needed Bacterial Special Pathogens Branch (CDC), , (404) 639-1711, bzb@cdc.gov
Alternate Phone, , (404) 772-5131,
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen http://www.cdc.gov/anthrax/labs/recommended_specimen.html


Type for Testing
Minimum Volume Required 100 uL - see Additional Information

Storage & Preservation of Info on specimens, storage and shipping can be found at:
Specimen Prior to Shipping http://www.cdc.gov/anthrax/labs/recommended_specimen.html

Transport Medium Dependent on specimen type submitted. Info on specimens, storage, and
shipping can be found at:
http://www.cdc.gov/anthrax/labs/recommended_specimen.html
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Info on appropriate specimens and shipping can be found at:
Include Specimen Handling http://www.cdc.gov/anthrax/labs/recommended_specimen.html
Requirements
Most samples can be sent 2-8C. Fresh tissue should be sent frozen and fixed
tissue can be sent at room temperature.
Methodology Culture, PCR, Immunohistochemistry (IHC), Toxin detection
Turnaround Time 2 Weeks
Interferences & Limitations Varies depending on tests used. Blood specimens should be collected in EDTA or
Sodium Citrate tubes (not heparin). Tissues for IHC should be formalin fixed.
Additional lnformation Turnaround time will vary depending on methods selected for detection at CDC.
Some methods may require up to 1 week.

Minimal volume: limited testing can be done with 100 ul, however 0.5- 1 ml is
optimal to increase number of tests which can be performed and increase assay
sensitivity.
CDC Points of Contact Alex Hoffmaster
(404) 639-0852
amh9@cdc.gov
Chung Marston
(404) 639-4057
cdk5@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 28 of 363


Test Order
Bacillus anthracis Genotyping and AST
CDC-10203

Synonym(s) Anthrax, Anthrax Gamma phage, Anthrax PCR, Anthrax typing


Pre-Approval Needed Bacterial Special Pathogens Branch (CDC), , (404) 639-1711, bzb@cdc.gov
Supplemental Information Select Agent Form 2 required for submission of all confirmed Select Agents.
Required
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen B. anthracis isolates


Type for Testing
Minimum Volume Required N/A

Storage & Preservation of Store isolates at room temperature


Specimen Prior to Shipping

Transport Medium Appropriate microbiological media for Bacillus


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Room temperature
Include Specimen Handling
Requirements Confirmed select agents need Form 2 approval by the Select Agent program prior
to shipping. The Form 2 can be found at
http://www.selectagents.gov/forms.html
Methodology Genotyping (i.e., MLVA and genome sequence), Broth Microdilution, Rapid
Antimicrobial Susceptibility Test (AST)
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation Rapid AST turnaround is 12-24 h.
Genotyping and broth microdilution is ~1 week.
Note: more extensive characterization by whole genome sequencing may take
longer. Times may be shorter in public health emergencies.

Link to our website:


http://www.cdc.gov/anthrax/labs/recommended_specimen.html
CDC Points of Contact Chung Marston
(404) 639-4057
cdk5@cdc.gov
David Lonsway
(404) 639-2825
dul7@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 29 of 363


Test Order
Bacillus anthracis Serology
CDC-10196

Synonym(s) Anthrax ELISA


Pre-Approval Needed Bacterial Special Pathogens Branch (CDC), , (404) 639-1711, bzb@cdc.gov
Alternate Phone, , (404) 772-5131,
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum (acute and convalescent required)


Type for Testing
Minimum Volume Required 250 uL

Storage & Preservation of Separate serum from clot; sera should be frozen immediately following
Specimen Prior to Shipping separation and stored frozen at -20C or colder, and should be shipped frozen
on dry ice to CDC, in appropriately labeled plastic screw cap vials. For more
information on specimen processing and storage, see link in "Additional
Information".
Transport Medium Not applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice. See additional info at
http://www.cdc.gov/anthrax/labs/recommended_specimen.html .
Methodology Antibody detection by ELISA and TNA
Turnaround Time 2 Weeks
Interferences & Limitations Requires acute and convalescent serum for analysis
Additional lnformation Turnaround time ranges from 1-2 weeks. See additional info at
http://www.cdc.gov/anthrax/labs/recommended_specimen.html
CDC Points of Contact Chung Marston
(404) 639-4057
cdk5@cdc.gov
Robyn Stoddard
(404) 639-2053
frd8@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 30 of 363


Test Order
Bacillus anthracis Study
CDC-10205

Synonym(s) None
Pre-Approval Needed Hoffmaster, Alex, (404) 639-0852, amh9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Alex Hoffmaster
(404) 639-0852
amh9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 31 of 363


Test Order
Bacillus cereus Detection - Foodborne Outbreak
CDC-10104

Synonym(s) None
Pre-Approval Needed Luquez, Carolina, (404) 639-0896, fry6@cdc.gov
Gomez, Gerry, (404) 639-0537, goe4@cdc.gov
Supplemental Information Only specimens from foodborne outbreaks accepted. Consult with EDLB
Required contact before sending specimens. Provide preliminary results if available.
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, food, stool. Only specimens from foodborne outbreaks accepted.
Type for Testing Consult with Carolina Luquez before sending specimens.
Minimum Volume Required 25 g (food) and 10g (stool)

Storage & Preservation of Food and stool should be maintained at 4C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Carolina Luquez (fry6@cdc.gov) and Gerry Gomez (goe4@cdc.gov) once
Requirements specimens have been shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology Toxin Detection in food, Culture, PCR
Turnaround Time 2 Months
Interferences & Limitations None
Additional lnformation Direct toxin detection requires food samples
CDC Points of Contact Carolina Luquez
(404) 639-0896
fry6@cdc.gov
Gerry Gomez
(404) 639-0537
goe4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 32 of 363


Test Order
Bacillus cereus Genotyping
CDC-10206

Synonym(s) Bacillus MLST


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Any medium can be submitted, but preferably agar slants
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Agar slants need to be shipped at room temperature
Methodology Multilocus sequence typing (MLST)
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation Testing can be done on B. cereus and B. thuringiensis
CDC Points of Contact Alex Hoffmaster
(404) 639-0852
amh9@cdc.gov
Jay Gee
(404) 639-4936
xzg4@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 33 of 363


Test Order
Bacillus species ID (Not B. anthracis)
CDC-10142

Synonym(s) Bacillus Identification


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary culture based on specimen type, 16S sequence based identification,
MALDI-TOF
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 34 of 363


Test Order
Bacterial ID from Clinical Specimen ( S rRNA PCR)
CDC-10146

Synonym(s) None
Pre-Approval Needed McQuiston, John, (404) 639-0270, zje8@cdc.gov
Whitney, Anne, (404) 639-1374, amw0@cdc.gov
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Primary specimens with prior approval


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 35 of 363


Test Order
Bacterial ID of Unknown Isolate (Not Strict Anaerobe)
CDC-10145

Synonym(s) Bacterial Identification


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 36 of 363


Test Order
Balamuthia Molecular Detection
CDC-10474

Synonym(s) Free-living ameba, parasite


Pre-Approval Needed None
Supplemental Information Please provide the following information: history of present illness, exposure
Required history, past medical history, treatment history, CSF results, imaging results. If
images are available please upload to: http://www.cdc.gov/dpdx
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen For Acanthamoeba and Balamuthia molecular detection, tissue is the preferred
Type for Testing specimen type; however, these amebae can occasionally be detected in
cerebrospinal fluid (CSF; see 'Interference & Limitations' below). For Naegleria
fowleri molecular detection, CSF is the preferred specimen type.
Minimum Volume Required 0.2 g tissue: 1 mL fluids

Storage & Preservation of Storage and preservation is specimen specific


Specimen Prior to Shipping

Transport Medium Small piece of tissue should be transported in small amount of 0.5x PBS to
prevent dryness.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. In addition to two patient identifiers
(sex, date of birth, name, etc.), provide specimen type and date of collection.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Please contact
Include Specimen Handling laboratory prior to shipping any specimen and include "Unit 53" on the outside
Requirements of package. Ship specimen at room temperature, not on dry ice, as an etiologic
agent, unless the specimen has been previously frozen. Frozen specimens may
be shipped in cold with ice-packs. Please send the shipment tracking number on
the day of shipment by e-mail to the CDC Point of Contacts (see below).
Methodology Real-time PCR
Turnaround Time 7 Days
Interferences & Limitations Formalin-fixed specimens are not suitable for molecular studies as formalin
fixation may cause DNA degradation. Fresh or frozen specimens, if available, are
preferred. Additionally, CSF is NOT the preferred specimen type for
Acanthamoeba or Balamuthia detection, because a negative CSF test result does
not completely rule out infections with these amebae.
Additional lnformation None
CDC Points of Contact Jennifer Cope
(404) 718-4878
bjt9@cdc.gov
Ibne Ali
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 37 of 363


Test Order
Bartonella henselae/B. quintana Indirect Fluorescent Antibody
(IFA) test
CDC-10486
Synonym(s) B. henselae/cat scratch disease, B. quintana/trench fever
Pre-Approval Needed None
Supplemental Information Please provide submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, date of symptom onset, sample collection date, and clinical information
including symptoms and type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 500 uL

Storage & Preservation of Sera may be stored at 2-8C for up to 14 days. If testing is delayed for a longer
Specimen Prior to Shipping period, serum samples may be frozen.

Transport Medium Not Applicable


Specimen Labeling Specimen identifier and patient name
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Indirect Fluorescent Antibody (IFA)
Turnaround Time 2 Weeks
Interferences & Limitations Samples with hemolysis, increased lipemia or microbial growth may interfere
with test results
Additional lnformation Clinical information including symptoms and date of onset must be included;
specimens without this accompanying information will not be tested.
CDC Points of Contact Jeannine Peterson
(970) 266-3524
nzp0@cdc.gov
Marty Schriefer
(970) 221-6479
mms7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 38 of 363


Test Order
Bartonella Special Study
CDC-10297

Synonym(s) Cat scratch fever, B. henselae, Trench fever, B. quintana, Oroya fever, B.
bacilliformis
Pre-Approval Needed Schriefer, Marty, (970) 221-6479, mms7@cdc.gov
Peterson, Jeannine, (970) 266-3524, nzp0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Molecular detection, Serology, Culture, Immunohistochemistry (IHC), Other
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Peterson
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 39 of 363


Test Order
Baylisascariasis Serology
CDC-10457

Synonym(s) Baylisascariasis, Raccoon roundworm, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors (raccoon)
Required clinical symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, plasma; Cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Immunoblot, Western Blot, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 40 of 363


Test Order
Biodefense R&D Study
CDC-10487

Synonym(s) Biodefense Research and Development Laboratory Study


Pre-Approval Needed Weigel, Linda, (404) 639-1497, lew9@cdc.gov
Sue, David, (404) 639-4027, btx6@cdc.gov
Supplemental Information For isolates from human specimens, prior approval is required. Consult with
Required the lab for details.

Select Agent Form 2 required for submission of all confirmed Select Agents.
The Form 2 can be found at
http://www.selectagents.gov/forms.html
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates on agar plate or slant, consult with lab for details.
Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Consult with lab for details


Specimen Prior to Shipping

Transport Medium Pure culture isolates (only) on sheep blood or Mueller-Hinton agar
Specimen Labeling Test is subject to CLIA regulations and requires two patient identifiers on the
specimen container and on the test requisition
Shipping Instructions which Select agents that have been identified need form 2 approval prior to shipping.
Include Specimen Handling Form 2 may be found at: http://www.selectagents.gov/forms.html
Requirements
Methodology Modified Broth Microdilution
Turnaround Time 2 Days
Interferences & Limitations Isolates from human specimens may be tested only under Emergency Use
Authorization.
Additional lnformation Turnaround time can vary depending on age/purity of isolate received
CDC Points of Contact Linda Weigel
(404) 639-1497
lew9@cdc.gov
David Sue
(404) 639-4027
btx6@cdc.gov

Tuesday, November 29, 2016 Version: 2.2 Page 41 of 363


Test Order
Biothreat Study
CDC-10432

Synonym(s) None
Pre-Approval Needed Bowzard, Brad, (404) 639-3626, jbowzard@cdc.gov
Andersen, Lauren, (404) 639-4442, wrh5@cdc.gov
Supplemental Information Please contact Dr. Brad Bowzard at 404 639-3626 or jbowzard@cdc.gov, for
Required the required supplemental form and packaging and shipping requirements.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Brad Bowzard
(404) 639-3626
jbowzard@cdc.gov
Lauren Andersen
(404) 639-4442
wrh5@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 42 of 363


Test Order
Blood Disorders Coagulation Study
CDC-10271

Synonym(s) Coag
Pre-Approval Needed Driggers, Jennifer, (404) 639-1269, jgq2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jennifer Driggers
(404) 639-1269
jgq2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 43 of 363


Test Order
Bordetella pertussis Serology
CDC-10166

Synonym(s) IgG against pertussis toxin, Pertussis ELISA, whooping cough


Pre-Approval Needed Pawloski, Lucia, (404) 639-4506, ecz6@cdc.gov
Tondella, Maria, (404) 639-1239, mlt5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum from patients with two or more weeks of cough, but will accept plasma if
Type for Testing serum is unavailable. Centrifuge the tube of blood at 1100-1300 x g for
approximately 10 minutes to separate the cells from the serum.
Minimum Volume Required 0.5 mL

Storage & Preservation of Serum specimens may be stored refrigerated (2-8C) for up to 7 days; If greater
Specimen Prior to Shipping than 7 days serum must be kept frozen (-20C or lower). For long-term storage,
the serum should be frozen (-20C or colder).
Transport Medium Not applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Serum specimens may be shipped refrigerated (2-8C) for up to 7 days. For
Include Specimen Handling shipments that are in transit for more than 7 days, specimens should be kept
Requirements frozen (-20C or lower). Sender is responsible for shipping charges and when
shipping internationally must request CDC's import permit and include this with
the Air Waybill. Additionally, the Pertussis/Diphtheria Laboratory requests that
the sender contact the laboratory by email or phone before shipping.
Methodology Enzyme-linked Immunosorbent Assay (ELISA)
Turnaround Time 5 Days
Interferences & Limitations Serum collected from patients with less than 2 weeks of cough are not
appropriate for this test. Samples should not be used if they have incurred more
than 5 freeze-thaw cycles. Specimens with unacceptable preservatives such as
anti-coagulants would invalidate the results.

In addition, hemolyzed and lipemic specimens are considered suboptimal serum


specimens for this assay.
Additional lnformation Please include patient age and duration of cough on specimen submission form
CDC Points of Contact Lucia Pawloski
(404) 639-4506
ecz6@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 44 of 363


Test Order
Bordetella species ID/Confirmation of Isolates
CDC-10164

Synonym(s) B. pertussis, B. parapertussis, B. holmesii, B. bronchiseptica, whooping cough


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolates on Regan-Lowe, Bordet-Gengou, charcoal agar or blood
Type for Testing agar (B. parapertussis, B. holmesii, or B. bronchiseptica only) or cryopreserved
isolates
Minimum Volume Required Not Applicable

Storage & Preservation of Isolates can be frozen in cryopreservation medium or refrigerated on Regan-
Specimen Prior to Shipping Lowe, Bordet-Gengou, charcoal agar or blood agar (B. parapertussis, B. holmesii,
or B. bronchiseptica only
Transport Medium Isolates can be frozen in cryopreservation medium or for best results a fresh
subculture on Regan-Lowe, Bordet-Gengou, charcoal agar or blood agar (B.
parapertussis, B. holmesii, or B. bronchiseptica only) should be sent refrigerated.
Calcium alginate and cotton swabs are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Isolates should be shipped refrigerated (2-8C) as soon as possible, between
Include Specimen Handling 24-48 hours. Frozen isolates should be sent on dry ice. Sender is responsible for
Requirements shipping charges and when shipping internationally must request CDC's import
permit and include this with the Air Waybill. Additionally, the
Pertussis/Diphtheria Laboratory requests that the sender contacts the laboratory
by email or phone before shipping.

Methodology Culture, Identification


Turnaround Time 2 Weeks
Interferences & Limitations Prior antibiotic treatment will adversely affect results and patients coughing
more than two weeks will likely not be culture positive.
Additional lnformation None
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 45 of 363


Test Order
Bordetella species Isolation and ID
CDC-10163

Synonym(s) B. pertussis, B. parapertussis, B. holmesii, B. bronchiseptica, whooping cough


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal (NP) swabs and aspirates; calcium alginate and cotton swabs are
Type for Testing not acceptable
Minimum Volume Required 0.5 mL aspirate

Storage & Preservation of Nasopharyngeal (NP) swabs should be collected on Dacron (polyester), rayon or
Specimen Prior to Shipping nylon. Specimens should be kept refrigerated. Use plastic/glass screw-cap, leak-
proof vials.
Transport Medium Regan-Lowe transport medium is recommended for specimens. Amies Charcoal
transports are acceptable, but may decrease the probability of isolation.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Swabs in transport or isolates should be shipped refrigerated (2-8C) as soon as
Include Specimen Handling possible, between 24-48 hours. Aspirates can be shipped with ice packs or
Requirements frozen (-20C or lower). Frozen isolates should be sent on dry ice. Sender is
responsible for shipping charges and when shipping internationally must request
CDC's import permit and include this with the Air Waybill. Additionally, the
Pertussis/Diphtheria Laboratory requests that the sender contacts the laboratory
by email or phone before shipping.
Methodology Culture
Turnaround Time 2 Weeks
Interferences & Limitations Prior antibiotic treatment will adversely affect results. Patients coughing more
than two weeks will likely not be culture positive.
Additional lnformation None
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 46 of 363


Test Order
Bordetella species Molecular Detection
CDC-10165

Synonym(s) None
Pre-Approval Needed Cassiday, Pam, (404) 639-1231, pxc1@cdc.gov
Tondella, Maria, (404) 639-1239, mlt5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Prefer nasopharyngeal aspirate but will also accept nasopharyngeal swab.
Type for Testing Calcium alginate and cotton swabs are not acceptable.
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimens should be kept refrigerated or frozen. Use plastic/glass screw-cap,
Specimen Prior to Shipping leak-proof vials

Transport Medium Dry swabs in sterile tubes are preferred; if only one swab is collected for both
culture and PCR, the swabs should be sent in Regan-Lowe transport.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol.


Shipping Instructions which Swabs should be shipped refrigerated (2-8C) as soon as possible, between
Include Specimen Handling 24-48 hours. Aspirates can be shipped with ice packs or frozen (-20C or lower).
Requirements Sender is responsible for shipping charges and when shipping internationally
must request CDC's import permit and include this with the Air Waybill.
Additionally, the Pertussis/Diphtheria Laboratory requests that the sender
contacts the laboratory by email or phone before shipping.
Methodology Polymerase Chain Reaction (PCR), Real Time Polymerase Chain Reaction (PCR),
Multi target Polymerase Chain Reaction (PCR)
Turnaround Time 5 Days
Interferences & Limitations Prior antibiotic treatment will adversely affect results. Specimens collected from
patients with more than 4 weeks of cough are not appropriate for this test.
Samples should not be used if they have incurred more than 2 freeze-thaw
cycles. Clinical specimens collected subsequent to initiation of antimicrobial
treatment may not be positive for Bordetella spp. Due to reduction of organisms.
Whenever possible, specimens collected prior to administration of antimicrobial
agents should be used to determine infection with Bordetella spp.
Additional lnformation None
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 47 of 363


Test Order
Bordetella species Study
CDC-10167

Synonym(s) None
Pre-Approval Needed Cassiday, Pam, (404) 639-1231, pxc1@cdc.gov
Tondella, Maria, (404) 639-1239, mlt5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 48 of 363


Test Order
Bordetella spp. ID (Not B. pertussis/B. parapertussis)
CDC-10143

Synonym(s) Bordetella Identification


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 49 of 363


Test Order
Borrelia burgdorferi (Lyme Disease) Serology
CDC-10298

Synonym(s) Lyme Disease, Borreliosis


Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Sera may be stored at 2-8C for up to 14 days. If testing is delayed for a longer
Specimen Prior to Shipping period, serum samples may be frozen.

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. Commonly used identifiers are the
first and last name and date of birth of the patient.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology IgG/IgM ELISA, IgG Western Blot, IgM Western Blot
Turnaround Time 3 Weeks
Interferences & Limitations Hemolyzed samples may interfere with test results
Additional lnformation Two tier testing will be performed. If available, submit any preliminary results.
Include the date of onset, antibiotic treatment (type of antibiotics and date
administered), date when the sample was collected, signs and symptoms.

If testing needs to be performed by another laboratory, i.e. arborvirus, please


contact laboratory prior to shipping.
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.5 Page 50 of 363


Test Order
Borrelia Culture and Identification
CDC-10299

Synonym(s) Lyme Disease, Borreliosis, Relapsing fever


Pre-Approval Needed Schriefer, Marty, (970) 221-6479, mms7@cdc.gov
Petersen, Jeannine, (970) 266-3524, nzp0@cdc.gov
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood, skin biopsy (Erythema Migrans Rash) and others upon consultation (i.e.
Type for Testing cultures, blood smears for confirmation, spinal fluid, synovial fluid)
Minimum Volume Required 0.5 mL

Storage & Preservation of For a skin biopsy, contact laboratory prior to collection and/or shipment for
Specimen Prior to Shipping specific requirements. Blood may be collected in heparin, citrate or EDTA. All
specimen should be collected and shipped prior to antibiotic treatment if
possible.
Transport Medium Contact laboratory prior to shipping for instructions on skin biopsy's transport
medium.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. Commonly used identifiers are the
first and last name and date of birth of the patient.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Culture, Microscopy Confirmation
Turnaround Time 8 Weeks
Interferences & Limitations Antibiotic treatment will minimize growth potential of culture
Additional lnformation Provide any antibiotic treatment information
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 51 of 363


Test Order
Borrelia hermsii (Tick-borne Relapsing Fever) Serology
CDC-10399

Synonym(s) Borreliosis, Recurrent fever, Borrelia


Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Keep specimen either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. Commonly used identifiers are the
first and last name and date of birth of the patient.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology IgM/IgG ELISA
Turnaround Time 3 Weeks
Interferences & Limitations Hemolyzed specimen can affect the results
Additional lnformation Two tier testing will be performed. If available, submit any preliminary results.
Include the date of onset, antibiotic treatment (type of antibiotics and date
administered), date when the sample was collected, signs and symptoms.

If testing needs to be performed by another laboratory, i.e. arborvirus, please


contact laboratory prior to shipping.
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 2.3 Page 52 of 363


Test Order
Borrelia Special Study
CDC-10300

Synonym(s) None
Pre-Approval Needed Schriefer, Marty, (970) 221-6479, mms7@cdc.gov
Petersen, Jeannine, (970) 266-3524, nzp0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 53 of 363


Test Order
Botulinum Toxin Producing Clostridia Subtyping
CDC-10134

Synonym(s) Bot, Botulism


Pre-Approval Needed Luquez, Carolina, (404) 639-0896, fry6@cdc.gov
Maslanka, Susan, (404) 639-0895, sht5@cdc.gov
Supplemental Information APHIS/CDC Form 2 Request to Transfer Select Agents and Toxins is required
Required
Supplemental Form http://www.selectagents.gov/forms.html

Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Chopped Meat Glucose Starch (CMGS) or Trypticase Peptone Glucose Yeast
extract (TPGY) media.
Specimen Labeling Not Applicable
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Package must have proper labeling for infectious substance: UN 2814 Infectious
substance, Category A
Methodology Pulsed field gel electrophoresis (PFGE)
Turnaround Time 12 Weeks
Interferences & Limitations None
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form. APHIS/CDC Form 2 must be approved prior to shipping. Form 2 may be
found at: http://www.selectagents.gov/forms.html ; Please send to POC:
anticipated arrival date, courier, and tracking number.
CDC Points of Contact Carolina Luquez (Primary POC)
(404) 639-0896
fry6@cdc.gov
Susan Maslanka (Alternate POC)
(404) 639-0895
sht5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 54 of 363


Test Order
Botulism Laboratory Confirmation
CDC-10132

Synonym(s) Bot, Botulism


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Foodborne: serum, stool, vomitus, gastric contents, and food
Type for Testing Wound: serum, debrided tissue, swab from wounds, and stool (to rule out
foodborne botulism)
Infant: stool, rectal swabs, and potential sources
Minimum Volume Required See Additional Information

Storage & Preservation of Maintain specimen at 4C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Packages may arrive on weekends
Include Specimen Handling
Requirements Ship with on cold packs. Package must have proper labeling for biological
hazards: UN 3373 biological substance, Category B.
Methodology Mouse Bioassay, ELISA, Mass Spectrometry (MS), Polymerase Chain Reaction (PCR)
Turnaround Time 12 Weeks
Interferences & Limitations None
Additional lnformation Serum samples must be collected before antitoxin treatment.

Adult patients: 5 to 15 ml of serum (without anticoagulant); 10 to 20 g of feces


(if an enema is needed, use sterile non-bacteriostatic water). Infant patients:
ideally, 10g to 20g of feces should be collected; however, smaller quantities can
provide confirmatory test results (if an enema is needed, use sterile non-
bacteriostatic water).

Foods should be left in their original containers or placed in sterile unbreakable


containers. Empty containers with remnants of suspected foods can also be
recovered and submitted for testing.
CDC Points of Contact Carolina Luquez (Primary POC)
(404) 639-0896
fry6@cdc.gov
Susan Maslanka (Alternate POC)
(404) 639-0895
sht5@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 55 of 363


Test Order
Botulism Special Study
CDC-10133

Synonym(s) None
Pre-Approval Needed Luquez, Carolina, (404) 639-0896, fry6@cdc.gov
Maslanka, Susan, (404) 639-0895, sht5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Carolina Luquez (Primary POC)
(404) 639-0896
fry6@cdc.gov
Susan Maslanka (Alternate POC)
(404) 639-0895
sht5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 56 of 363


Test Order
Brucella species Identification, Genotyping, and AST
CDC-10207

Synonym(s) Brucellosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Blood/serum, tissue, joint fluid, environmental/nonclinical samples and culture
Type for Testing isolates
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Agar slants preferred for shipping isolates


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Select agents that have been identified need form 2 approval prior to shipping.
Include Specimen Handling Form 2 may be found at: http://www.selectagents.gov/forms.html
Requirements Select agents must be shipped Monday through Wednesday to prevent weekend
arrivals
Agar slants should be shipped at room temperature and specimens at 4C.
Methodology Polymerase Chain Reaction (PCR), Biochemicals, Phage Suseptability, Broth Micro
Dilution, MLVA
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation Turnaround time will vary depending on if an isolate is sent for identification or
a specimen is sent for isolation. Identification of isolates generally is completed
within 1 week and susceptibility testing is completed within 2 weeks, while
isolation from specimens and subsequent ID may take up to 3 weeks.

For additional information please refer to the ASM sentinel laboratory guide:
http://www.asm.org/images/pdf/Clinical/Protocols/brucella10-15-04.pdf
CDC Points of Contact Rebekah Tiller
(404) 639-4507
eto3@cdc.gov
David Lonsway
(404) 639-2825
dul7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 57 of 363


Test Order
Brucella species Molecular Detection
CDC-10208

Synonym(s) Brucella PCR


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Blood/serum, tissue, joint fluid, environmental/nonclinical samples. Blood
Type for Testing specimens should be collected in EDTA or Sodium Citrate tubes (not heparin).
Minimum Volume Required 250 uL

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Blood specimens should be transported in EDTA or Sodium Citrate tubes at 4C
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Select agents that have been identified need form 2 approval prior to shipping.
Include Specimen Handling Form 2 can be found at: http://www.selectagents.gov/forms.html
Requirements
Select agents must be shipped Monday through Wednesday to prevent weekend
arrivals. Specimens should be shipped at 4C.
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Weeks
Interferences & Limitations Blood specimens should be collected in EDTA or Sodium Citrate tubes (not
heparin)
Additional lnformation For additional information please refer to the ASM sentinel laboratory guide:
http://www.asm.org/images/pdf/Clinical/Protocols/brucella10-15-04.pdf
CDC Points of Contact Rebekah Tiller
(404) 639-4507
eto3@cdc.gov
Alex Hoffmaster
(404) 639-0852
amh9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 58 of 363


Test Order
Brucella species Serology
CDC-10197

Synonym(s) BMAT
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum (acute and convalescent preferred)


Type for Testing
Minimum Volume Required 100 uL

Storage & Preservation of Serum needs to be stored at 4C


Specimen Prior to Shipping

Transport Medium Not applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship serum at 4C
Methodology Brucella microagglutination test (BMAT)
Turnaround Time 2 Weeks
Interferences & Limitations Acute and convalescent sera are preferred
No serology available for B. Canis or RB51
May have poor sensitivity for chronic or complicated brucellosis
Additional lnformation Acute and convalescent sera are preferred
CDC Points of Contact Robyn Stoddard
(404) 639-2053
frd8@cdc.gov
Renee Galloway
(404) 639-5461
zul0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 59 of 363


Test Order
Brucella species Study
CDC-10209

Synonym(s) None
Pre-Approval Needed Stodard, Robyn, (404) 639-2053, frd8@cdc.gov
Tiller, Rebekah, (404) 639-4507, eto3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Robyn Stoddard
(404) 639-2053
frd8@cdc.gov
Rebekah Tiller
(404) 639-4507
eto3@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 60 of 363


Test Order
Burkholderia mallei/pseudomallei Identification, Genotyping
and AST
CDC-10210
Synonym(s) Glanders, Melioidosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, clinical specimens (blood, bone marrow, sputum or bronchoscopically
Type for Testing obtained specimens, abscess material or wound swabs, and urine)
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Agar slants preferred for isolates


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition
Shipping Instructions which Select agents that have been identified need form 2 approval prior to shipping.
Include Specimen Handling Form 2 can be found at http://www.selectagents.gov/forms.html
Requirements Select agents must be shipped Monday through Wednesday to prevent weekend
arrivals. Specimens should be shipped at 4C.
Methodology Polymerase Chain Reaction (PCR), Biochemicals, Broth Micro Dilution, Multilocus
sequence typing (MLST), Multiple-Locus Variable number tandem repeat
Analysis (MLVA)
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation Turnaround time will vary depending on if an isolate is sent for identification or
a specimen is sent for isolation. Identification of isolates generally is completed
within 3 days while isolation from specimens and subsequent ID may take up to
10 days.
For additional information please refer to the ASM sentinel laboratory guide:
http://asm.org/images/pdf/Clinical/Protocols/bpseudomallei2008.pdf
CDC Points of Contact Mindy Elrod
(404) 639-4055
wzg0@cdc.gov
David Lonsway
(404) 639-2825
dul7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 61 of 363


Test Order
Burkholderia mallei/pseudomallei Molecular Detection
CDC-10211

Synonym(s) Glanders, Melioidosis


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form http://www.selectagents.gov/forms.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Blood, bone marrow, sputum or bronchoscopically obtained specimens, abscess
Type for Testing material or wound swabs, urine, and serum; blood specimens should be
collected in EDTA or Sodium Citrate tubes (not heparin)
Minimum Volume Required 250 uL

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Dependent on specimen type


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition
Shipping Instructions which Select agents that have been identified need form 2 approval prior to shipping.
Include Specimen Handling Form 2 can be found at http://www.selectagents.gov/forms.html
Requirements Select agents must be shipped Monday through Wednesday to prevent weekend
arrivals. Specimens should be shipped at 4C. Select agents must be shipped
Monday through Wednesday to prevent weekend arrivals. Agar slants should be
shipped at room temperature and specimens at 4C.
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Weeks
Interferences & Limitations Blood specimens should be collected in EDTA or Sodium Citrate tubes (not
heparin)
Additional lnformation For additional information please refer to the ASM sentinel laboratory guide:
http://asm.org/images/pdf/Clinical/Protocols/bpseudomallei2008.pdf
CDC Points of Contact Jay Gee
(404) 639-4936
xzg4@cdc.gov
Mindy Elrod
(404) 639-4055
wzg0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 62 of 363


Test Order
Burkholderia mallei/pseudomallei Study
CDC-10212

Synonym(s) None
Pre-Approval Needed Elrod, Mindy, (404) 639-4055, wzg0@cdc.gov
Gee, Jay, (404) 639-4936, xzg4@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Mindy Elrod
(404) 639-4055
wzg0@cdc.gov
Jay Gee
(404) 639-4936
xzg4@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 63 of 363


Test Order
Burkholderia pseudomallei Serology
CDC-10198

Synonym(s) Melioidosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum (acute and convalescent required)


Type for Testing
Minimum Volume Required 100 uL

Storage & Preservation of Store serum at 4C before shipping


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Serum should be shipped at 4C
Methodology IHA-indirect haemagglutantion
Turnaround Time 2 Weeks
Interferences & Limitations Acute and convalescent are required.
Additional lnformation Turnaround time may be shorter depending on risk and need
CDC Points of Contact Alex Hoffmaster
(404) 639-0852
amh9@cdc.gov
Mindy Elrod
(404) 639-4055
wzg0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 64 of 363


Test Order
Burkholderia spp. ID (Not B. mallei/B. pseudomallei)
CDC-10144

Synonym(s) Burkholderia Identification


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 65 of 363


Test Order
Campylobacter and Helicobacter Study
CDC-10125

Synonym(s) Campy, H. pylori


Pre-Approval Needed Pruckler, Janet, (404) 639-4770, jmp5@cdc.gov
Korth, Michael, (404) 639-2099, mqk8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Janet Pruckler
(404) 639-4770
jmp5@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 66 of 363


Test Order
Campylobacter species serology
CDC-10455

Synonym(s) Enteric Pathogen


Pre-Approval Needed Aubert, Rachael, (404) 639-3816, vrl7@cdc.gov
Korth, Michael, (404) 639-2099, mqk8@cdc.gov
Supplemental Information Date of illness onset, date of serum collection, clinical diagnosis (i.e. Guillain
Required Barr).
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired serum is preferred. Serum is always preferred but plasma is acceptable.
Type for Testing Do not pool specimens.
Minimum Volume Required 100 uL (More Preferred)

Storage & Preservation of Maintain serum at 4C (preferred); frozen specimens acceptable


Specimen Prior to Shipping

Transport Medium Separate serum from the clot and ship in a sterile labeled tube with the top
tightly closed
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Rachael Aubert (vrl7@cdc.gov, (404) 639-3816) once specimens have been
Requirements shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology EIA
Turnaround Time 3 Months
Interferences & Limitations None
Additional lnformation Paired serum specimens always preferred.

Please send one tube per specimen submission form. Submit multiple forms if
needed.
CDC Points of Contact Rachael Aubert
(404) 639-3816
vrl7@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 67 of 363


Test Order
Campylobacter, Helicobacter, and Related Organisms
Identification
CDC-10126
Synonym(s) Campy, H. pylori
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens; Please call for approval
Required prior to sending other specimen types. Provide any preliminary results
available.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship overnight growth on nonselective blood-based slant/stab (preferably not
TSA); screw cap tubes preferred
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements Ship with cold packs in compliance with federal and local guidelines.

There are no time constraints for submitting sequence data


Methodology Phenotypic Identification, Genetic Identification
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Janet Pruckler
(404) 639-4770
jmp5@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 68 of 363


Test Order
Campylobacter, Helicobacter, and Related Organisms
Identification and Subtyping
CDC-10127
Synonym(s) Campy, H. pylori
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens; Please call for approval
Required prior to sending other specimen types. Provide any preliminary results
available.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship overnight growth on nonselective blood-based slant/stab (preferably not
TSA); screw cap tubes preferred
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements Ship with cold packs in compliance with federal and local guidelines.

There are no time constraints for submitting sequence data


Methodology Phenotypic Identification, Genetic Identification, Penner Serotyping, PFGE, AST
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form. Epidemiologic metadata, PulseNet cluster code, and PFGE pattern
designation requested if available.

Turnaround times for routine isolates may be extended during major foodborne
outbreak activities due to limited availability of resources.
CDC Points of Contact Janet Pruckler
(404) 639-4770
jmp5@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 69 of 363


Test Order
Chagas Disease Molecular Detection
CDC-10475

Synonym(s) Trypanosoma cruzi; American trypanosomiasis, parasite


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood, Heart Biopsy Tissue, and CSF


Type for Testing
Minimum Volume Required 2.2 ml (pediatric 0.2 ml)

Storage & Preservation of Collect about 5 ml blood sample in Vacutainer EDTA tubes prior to anti-
Specimen Prior to Shipping parasitic therapy and store at 4C

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling on wet ice (cold pack) as an etiologic agent.
Requirements
Methodology Real-time PCR
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Theresa Benedict
(404) 718-4124
tgd5@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 70 of 363


Test Order
Chagas Disease Serology
CDC-10458

Synonym(s) Trypanosoma cruzi; American trypanosomiasis, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Indirect Fluorescent Antibody Assay, EIA, ELISA, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Hilda Rivera
(404) 718-4100
igi2@cdc.gov
Sue Montgomery
(404) 718-4731
zqu6@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 71 of 363


Test Order
Chlamydia pneumoniae Molecular Detection
CDC-10152

Synonym(s) Chlamydia pneumoniae, Atypical pneumonia, CAP, Chlamydia


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal (NP) and/or Oropharyngeal (OP) swabs, and any lower
Type for Testing respiratory tract specimen including bronchoalveolar lavage (BAL) and sputum;
tissue, cerebral spinal fluid, isolates and purified nucleic acid; Others upon
consultation with laboratory.
Minimum Volume Required Contingent upon specimen type. Please call for consultation

Storage & Preservation of Specimens can be kept refrigerated if shipped in less than 72 hours of collection;
Specimen Prior to Shipping otherwise specimen should be kept frozen. Store swabs in universal transport
medium.
Transport Medium Universal transport medium
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be sent on ice packs
Frozen specimen should be sent on dry ice
Methodology Real-Time PCR
Turnaround Time 7 Days
Interferences & Limitations Do not use cotton swabs with wooden shafts. Specimen should be acquired prior
to antibiotic treatment. Improper specimen storage and handling may result in
inconclusive or inaccurate results.
Additional lnformation All specimens are tested as a part of a multiplex qPCR detecting M. pneumoniae,
C. pneumoniae, and Legionella species. See also CDC-10157
CDC Points of Contact Jonas Winchell
(404) 639-4921
Jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 72 of 363


Test Order
Chlamydia psittaci Molecular Detection
CDC-10153

Synonym(s) Psittacosis, Parrot fever, Chlamydia psittaci


Pre-Approval Needed Winchell, Jonas, (404) 639-4921, Jwinchell@cdc.gov
Diaz, Maureen, (404) 639-4534, mdiaz1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal (NP) and/or Oropharyngeal (OP) swabs, and any lower
Type for Testing respiratory tract specimen including bronchoalveolar lavage (BAL) and sputum;
tissue, cerebral spinal fluid , isolates and purified nucleic acid; Others upon
consultation with laboratory.
Minimum Volume Required Contingent upon specimen type. Please call for consultation

Storage & Preservation of Tissues should be kept frozen. All other specimens can be kept refrigerated if
Specimen Prior to Shipping shipped less than 72 hrs of collection; otherwise specimens should be kept
frozen. Store swabs in universal transport medium.
Transport Medium Universal transport medium
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be sent on ice packs
Frozen specimen should be sent on dry ice
Methodology Real Time PCR
Turnaround Time 7 Days
Interferences & Limitations Do not send fixed tissues. Do not use cotton swabs with wooden shafts.
Specimen should be acquired prior to antibiotic treatment. Improper specimen
storage and handling may result in inconclusive or inaccurate results.
Additional lnformation If specimen is not of human origin please contact Dr. Branson Ritchie at the
University of Georgia
CDC Points of Contact Jonas Winchell
(404) 639-4921
Jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 3.0 Page 73 of 363


Test Order
Chlamydia species Study
CDC-10158

Synonym(s) None
Pre-Approval Needed Winchell, Jonas, (404) 639-4921, Jwinchell@cdc.gov
Diaz, Maureen, (404) 639-4534, mdiaz1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation This test only refers to studies involving respiratory Chlamydia species
specifically Chlamydia pneumoniae and Chlamydia psittaci.

CDC Points of Contact Jonas Winchell


(404) 639-4921
Jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 74 of 363


Test Order
Chlamydia trachomatis, Genital - Molecular Detection
CDC-10192

Synonym(s) Chlamydia trachomatis (CT) NAATS, Chlamydia


Pre-Approval Needed None
Supplemental Information Please indicate the product or medium used for storage and/or transport.
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Oral pharynx swabs, cervical swabs, vaginal swabs, and rectal swabs collected on
Type for Testing any commercially available product, and urine
Minimum Volume Required 5 mL (urine)

Storage & Preservation of Adhere to product insert instructions for swabs


Specimen Prior to Shipping

Transport Medium Adhere to product insert instructions for swabs


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped on dry ice if previously frozen, as an etiologic agent.
Requirements
Methodology Nucleic Acid Amplification Tests (NAATS)
Turnaround Time 2 Weeks
Interferences & Limitations Adhere to product insert instructions for swabs
Additional lnformation None
CDC Points of Contact John Papp
(404) 639-3785
jwp6@cdc.gov
Christi Phillips
(404) 639-2147
div2@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 75 of 363


Test Order
Chlamydia trachomatis, Genital - Study
CDC-10193

Synonym(s) None
Pre-Approval Needed Papp, John, (404) 639-3785, jwp6@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact John Papp
(404) 639-3785
jwp6@cdc.gov
Christi Phillips
(404) 639-2147
div2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 76 of 363


Test Order
Clinical Microbiology Reference Study
CDC-10231

Synonym(s) None
Pre-Approval Needed Rasheed, Kamile, (404) 639-3247, JRasheed@cdc.gov
Limbago, Brandi, (404) 639-2162, Blimbago@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Kamile Rasheed
(404) 639-3247
JRasheed@cdc.gov
Brandi Limbago
(404) 639-2162
Blimbago@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 77 of 363


Test Order
Clostridium difficile Identification
CDC-10228

Synonym(s) C. Difficile ID, C. diff


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Pure culture isolates in suitable anaerobic transport medium (e.g., Chopped Meat
Type for Testing Glucose Broth)
Minimum Volume Required Not Applicable

Storage & Preservation of Store anaerobically


Specimen Prior to Shipping

Transport Medium Pure culture isolate in Chopped Meat Glucose Broth, thioglycolate broth or
frozen in TSB plus glycerol
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries, as an
Include Specimen Handling etiologic agent.
Requirements
Frozen specimen should be shipped on dry ice
Specimen stored at room temperature should be shipped at room temperature
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation This test does not include strain typing or characterization
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Kamile Rasheed
(404) 639-3247
jkr1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 78 of 363


Test Order
Clostridium difficile Outbreak Strain Typing
CDC-10229

Synonym(s) C. Difficile Toxin, C. difficile Characterization


Pre-Approval Needed Rasheed, Kamile, (404) 639-3247, JRasheed@cdc.gov
Karlsson, Maria, (404) 639-0698, fwt4@cdc.gov
Supplemental Information Prior approval and Epidemiologic consultation required.
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate. Additional specimen types accepted upon consultation with
Type for Testing laboratory
Minimum Volume Required Not Applicable

Storage & Preservation of Store anaerobically


Specimen Prior to Shipping

Transport Medium Pure culture isolate in Chopped Meat Glucose Broth, thioglycolate broth or
frozen in TSB plus glycerol
Specimen Labeling Include date of isolation and unique specimen identifier
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries, as an
Include Specimen Handling etiologic agent.
Requirements
Frozen specimen should be shipped on dry ice
Specimen stored at room temperature should be shipped at room temperature
Methodology Molecular Strain Typing, Phenotypic Testing
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation Not CLIA compliant testing; for epidemiologic purposes only
CDC Points of Contact Kamile Rasheed
(404) 639-3247
JRasheed@cdc.gov
Maria Karlsson
(404) 639-0698
fwt4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 79 of 363


Test Order
Clostridium perfringens Detection - Foodborne Outbreak
CDC-10111

Synonym(s) C. perfringens
Pre-Approval Needed Luquez, Carolina, (404) 639-0896, fry6@cdc.gov
Gomez, Gerry, (404) 639-0537, goe4@cdc.gov
Supplemental Information Only specimens from foodborne outbreaks accepted. Consult with EDLB
Required contact before sending specimens. Provide any preliminary results available.
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, stool and food. Only specimens from foodborne outbreaks accepted.
Type for Testing Consult with Carolina Luquez and Gerry Gomez before sending specimens.
Minimum Volume Required 10 g (stool) and 25 g (food)

Storage & Preservation of Maintain stool and food at 4C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Carolina Luquez (fry6@cdc.gov) and Gerry Gomez (goe4@cdc.gov) once
Requirements specimens have been shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology Toxin Detection in Stool, Culture, PCR
Turnaround Time 2 Months
Interferences & Limitations None
Additional lnformation Direct toxin detection requires stool specimens
CDC Points of Contact Carolina Luquez
(404) 639-0896
fry6@cdc.gov
Gerry Gomez
(404) 639-0537
goe4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 80 of 363


Test Order
Congo-Crimean Hemorrhagic Fever Identification
CDC-10302

Synonym(s) CCHF
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 81 of 363


Test Order
Congo-Crimean Hemorrhagic Fever Serology
CDC-10303

Synonym(s) CCHF
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 82 of 363


Test Order
Corynebacterium diphtheriae Study
CDC-10172

Synonym(s) None
Pre-Approval Needed Cassiday, Pam, (404) 639-1231, pxc1@cdc.gov
Tondella, Maria, (404) 639-1239, mlt5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 83 of 363


Test Order
Corynebacterium diphtheriae Toxin - Molecular Detection
CDC-10171

Synonym(s) Diphtheria, Real Time PCR


Pre-Approval Needed Cassiday, Pam, (404) 639-1231, pxc1@cdc.gov
Tondella, Maria, (404) 639-1239, mlt5@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolates on a suitable agar slant, extracted DNA, or
Type for Testing pseudomembrane
Minimum Volume Required 100 uL (DNA)

Storage & Preservation of Specimens should be kept refrigerated or frozen. Use plastic/glass screw-cap,
Specimen Prior to Shipping leak-proof vials. Pseudo-membrane should be sent in leak-proof container with
saline, not formalin.
Transport Medium Common transport media such as Amies or Stuart may be used for swabs.
Isolates should be sent on blood agar slants or TSA. Pseudo-membrane should
be sent in leak-proof container with saline not formalin.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Once specimens are collected they should be shipped to the laboratory as soon
Include Specimen Handling as possible, between 24-48 hours. Sender is responsible for shipping charges
Requirements and when shipping internationally must request CDC's import permit and include
this with the Air Waybill. Additionally, the Pertussis/Diphtheria Laboratory
requests that the sender contacts the laboratory by email or phone before
shipping.
Methodology Real Time Polymerase Chain Reaction (RT-PCR)
Turnaround Time 5 Days
Interferences & Limitations Prior antibiotic treatment will adversely affect results. Suboptimal volumes of
specimens may adversely affect the sensitivity of tests performed therefore it is
very important to obtain an acceptable volume and a quality specimen. Clinical
specimens collected subsequent to initiation of antimicrobial treatment may not
be positive for Corynebacterium species due to reduction of organisms.
Whenever possible, specimens collected prior to administration of antimicrobial
agents should be used to determine infection with Corynebacterium species.
Additional lnformation Diphtheria Antitoxin (DAT) testing should be performed on the patient prior to
requesting molecular testing from CDC. Corynebacterium PCR testing is not
currently used for diagnostic purposes for diphtheria and is not considered a
confirmatory test.
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 84 of 363


Test Order
Corynebacterium diphtheriae/ulcerans/pseudotuberculosis ID
and Toxigenicity
CDC-10169
Synonym(s) Diphtheria
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Fresh subculture (24-48 hours old) of a pure culture isolate on a suitable agar
Type for Testing slant
Minimum Volume Required Not Applicable

Storage & Preservation of Use plastic/glass screw-cap, leak-proof vials. Isolates can be refrigerated on an
Specimen Prior to Shipping agar slant or common culture medium or frozen in TSB with glycerol or other
liquid medium.
Transport Medium Common transport medium such as blood agar, TSA, nutrient agar,
slants/plates, or frozen
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Once specimens are collected they should be shipped to the laboratory as soon
Include Specimen Handling as possible, between 24-48 hours. Sender is responsible for shipping charges
Requirements and when shipping internationally must request CDC's import permit and include
this with the Air Waybill. Additionally, the Pertussis/Diphtheria Laboratory
requests that the sender contacts the laboratory by email or phone before
shipping.
Methodology Culture, API Coryne, Elek, Polymerase Chain Reaction (PCR)
Turnaround Time 1 Week
Interferences & Limitations Isolates passed within 24-48 hours are preferred
Additional lnformation None
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 85 of 363


Test Order
Corynebacterium diphtheriae/ulcerans/pseudotuberculosis
Isolation, ID, Toxigenicity
CDC-10168
Synonym(s) Diphtheria
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Throat, nasal and wound swabs, pseudo-membrane, and sputum
Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Use plastic/glass screw-cap, leak-proof vials. Store refrigerated.
Specimen Prior to Shipping

Transport Medium Common transport media such as Amies or Stuart may be used for swabs.
Pseudo-membrane should be sent in leak-proof container with saline not
formalin.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Once specimens are collected they should be shipped to the laboratory as soon
Include Specimen Handling as possible, between 24-48 hours. Sender is responsible for shipping charges
Requirements and when shipping internationally must request CDC's import permit and include
this with the Air Waybill. Additionally, the Pertussis/Diphtheria Laboratory
requests that the sender contacts the laboratory by email or phone before
shipping.
Methodology Culture, Polymerase Chain Reaction (PCR), API Coryne, Elek
Turnaround Time 1 Week
Interferences & Limitations Prior antibiotic treatment will adversely affect results. Suboptimal volumes of
specimens may adversely affect the sensitivity of tests performed therefore it is
very important to obtain an acceptable volume and a quality specimen. Clinical
specimens collected subsequent to initiation of antimicrobial treatment may not
be positive for Corynebacterium species due to reduction of organisms.
Whenever possible, specimens collected prior to administration of antimicrobial
agents should be used to determine infection with Corynebacterium species.
Additional lnformation None
CDC Points of Contact Pam Cassiday
(404) 639-1231
pxc1@cdc.gov
Maria Tondella
(404) 639-1239
mlt5@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 86 of 363


Test Order
Corynebacterium species (Not C. diphtheriae) ID
CDC-10136

Synonym(s) Diptheria
Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 87 of 363


Test Order
Coxiella burnetii Molecular Detection
CDC-10304

Synonym(s) Q fever
Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Acute samples only, anticoagulated whole blood collected in
Type for Testing Ethylenediaminetetraacetic acid (EDTA) treated tubes preferred; serum; fresh
tissue biopsy
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Ethylenediaminetetraacetic acid (EDTA) blood tubes for blood; tissue in a sample
collection tube
Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Real Time Polymerase Chain Reaction (PCR), Polymerase Chain Reaction (PCR),
Sequencing
Turnaround Time 6 Weeks
Interferences & Limitations Hemolysis in whole blood specimen will interfere with results. Multiple freeze
thaw cycles and sample storage above refrigerated temperatures will interfere
with proper nucleic acid extraction. If a specimen is drawn at convalescence it
will reduce the chance of the target organism being present in blood. Avoid
collection of blood specimen in heparin tubes.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 88 of 363


Test Order
Coxiella burnetii Serology
CDC-10305

Synonym(s) Q fever
Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Indirect Fluorescence Assay (IFA)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact laboratory prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 89 of 363


Test Order
Coxiella Special Study
CDC-10306

Synonym(s) Q fever
Pre-Approval Needed Kato, Cecilia, (404) 639-1075, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 90 of 363


Test Order
Cryptosporidium Special Study
CDC-10491

Synonym(s) None
Pre-Approval Needed Roellig, Dawn M, (404) 718-4134, iyd4@cdc.gov
Xiao, Lihua, (404) 718-4161, lax0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From None

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Dawn M Roellig
(404) 718-4134
iyd4@cdc.gov
Lihua Xiao
(404) 718-4161
lax0@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 91 of 363


Test Order
Cyclospora Molecular Detection
CDC-10477

Synonym(s) Cyclospora cayetenensis, parasite


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool


Type for Testing
Minimum Volume Required 0.5 g or 0.5ml

Storage & Preservation of Stool collected in absence of preservatives must be kept refrigerated (4C) or
Specimen Prior to Shipping frozen. Stool samples in a PCR-compatible fixative, e.g. TotalFix, UniFix, EcoFix
and modified PVA (Zn- or Cu-based), can be kept at room temperature.
Alternatively stool specimens can also be mixed in potassium dichromate 2.5%
(1:1 dilution) or in absolute ethanol (1:1 dilution).
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship fixed/preserved
Include Specimen Handling stool at room temperature. Ship unpreserved stool on wet ice (cold pack) if
Requirements stored refrigerated or ship frozen (on dry ice) if stored frozen.
Methodology Real-Time PCR
Turnaround Time 21 Days
Interferences & Limitations Stool specimens fixed in formalin-containing preservatives or LV-PVA are not
suitable for molecular studies.
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Theresa Benedict
(404) 718-4124
tgd5@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 92 of 363


Test Order
Cysticercosis Serology
CDC-10459

Synonym(s) Neurocysticercosis, Taenia solium, cysitcercus, EITB, LLGP-EITB, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, plasma; Cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Immunoblot, Western Blot, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 93 of 363


Test Order
Cytomegalovirus (CMV) Detection
CDC-10263

Synonym(s) CMV
Pre-Approval Needed Dollard, Shelia, (404) 639-2178, sgd5@cdc.gov
Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Urine, saliva, and blood


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes.

Transport Medium Not Applicable


Specimen Labeling Provide a specimen ID. Do not send specimen labeled with patients name.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Shelia Dollard
(404) 639-2178
sgd5@cdc.gov
Scott Schmid
(404) 639-0066
dss1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 94 of 363


Test Order
Cytomegalovirus (CMV) Serology
CDC-10264

Synonym(s) CMV
Pre-Approval Needed Dollard, Sheila, (404) 639-2178, sgd5@cdc.gov
Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or plasma


Type for Testing
Minimum Volume Required 500 uL

Storage & Preservation of Keep specimen either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Provide a specimen ID. Do not send specimen labeled with patients name.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology IgG antibody detected by EIA, IgM antibody detected by EIA
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Sheila Dollard
(404) 639-2178
sgd5@cdc.gov
Scott Schmid
(404) 639-0066
dss1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 95 of 363


Test Order
Dengue Virus Diagnosis
CDC-10307

Synonym(s) Dengue fever, Dengue


Pre-Approval Needed None
Supplemental Information Dengue case investigation form must be filled out- See supplemental Form
Required
Additional Information on submitting specimen and the Spanish version of
case investigation form are located at:
http://www.cdc.gov/dengue/clinicalLab/laboratory.html
Supplemental Form http://www.cdc.gov/dengue/resources/dengueCaseReports/DCIF_English.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and others upon consultation with laboratory. The blood sample should
Type for Testing be taken in a red-top or tiger-top tube.
Minimum Volume Required 0.5 mL

Storage & Preservation of After blood is allowed to clot, separate serum by centrifugation and keep serum
Specimen Prior to Shipping refrigerated at 4C or frozen at -20C (preferred).

Citrate (collected in yellow top tubes) and heparin plasma (green top tubes) can
be tested by RT-PCR. Violet-top (with EDTA) is not recommended for RT-PCR
testing. Violet and or green-top tubes should not be used for serology testing
(convalescent sample). Please refer to collection devices manufacturer
instructions for more details.

We recommend freezing the serum immediately after it is separated and to send


on dry ice. If dry ice is not available, we recommend that the serum is kept
refrigerated and delivered to the CDC Dengue Branch in cold packs.
Transport Medium Not Applicable
Specimen Labeling Include complete name, age, and sex of patient, home address, date of onset of
symptoms, date sample was obtained, complete name and mailing address of
the physician, laboratory, clinic, or hospital
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on ice packs

Ship To:
CDC Dengue Branch and Puerto Rico Department of Health
1324 Calle Caada, San Juan, P. R. 00920-3860
Methodology IgM by ELISA, NS1 Antigen Test, Polymerase Chain Reaction (PCR), Viral isolation,
IgG seroconversion by ELISA
Turnaround Time 7 Days
Interferences & Limitations Serological tests can cross react with other Flavivirus, such as West Nile Virus.
Recent vaccinations for Yellow Fever Virus and Japanese Encephalitis Virus, Tick-
borne Encephalitis Virus can cause cross reactive test results. Natural infections
with St. Louis Encephalitis Virus and West Nile can cause cross reactive results.
Hemolyzed or contaminated samples are not acceptable for serology testing.
EDTA will affect PCR and serology results and Nitrate tubes will affect IgM
results.
Additional lnformation To diagnose dengue, the laboratory requires a serum sample obtained during

Tuesday, November 29, 2016 Version: 1.0 Page 96 of 363


Test Order
Dengue Virus Diagnosis
CDC-10307

the acute phase of the infection (DPO=0-5). If this sample is negative, then a
second convalescent serum sample (that can be taken from day 6 after the onset
of symptoms) is required to confirm the case. The case is confirmed with
antibody (IgM or IgG) seroconversion. Informing the patient about the
importance of returning for a second sample, and providing an appointment for
a specific day and hour, will increase the probability of obtaining the second
sample. Samples will be rejected if they are sent without form, form without
sample, incomplete or illegible form especially regarding date of onset of
symptoms, date of sample collection and samples received more than a month
after onset of illness.
CDC Points of Contact Elizabeth Hunsperger
(787) 706-2472
enh4@cdc.gov
Jorge Munoz
(787) 706-2460
ckq2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 97 of 363


Test Order
Dengue Virus Special Study
CDC-10308

Synonym(s) None
Pre-Approval Needed Hunsperger, Elizabeth, (787) 706-2472, enh4@cdc.gov
Munoz, Jorge, (787) 706-2469, ckq2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Elizabeth Hunsperger
(787) 706-2472
enh4@cdc.gov
Jorge Munoz
(787) 706-2469
ckq2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 98 of 363


Test Order
Ebola Identification
CDC-10309

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 99 of 363


Test Order
Ebola Serology
CDC-10310

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 100 of 363


Test Order
Echinococcosis Serology
CDC-10460

Synonym(s) Hydatid Disease, Echinococcus granulosus, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Immunoblot, Western Blot, Antibody detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 101 of 363


Test Order
Ehrlichia Molecular Detection
CDC-10499

Synonym(s) Human monocytic ehrlichiosis and HME


Pre-Approval Needed Kato, Cecilia, (404) 639-0152, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Acute samples only, anticoagulated whole blood collected in
Type for Testing Ethylenediaminetetraacetic acid (EDTA) treated tubes preferred; serum; fresh
tissue biopsy
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Ethylenediaminetetraacetic acid (EDTA) blood tubes for blood; tissue in a sample
collection tube
Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped refrigerated on cold packs.
Requirements
Methodology Real Time Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 6 Weeks
Interferences & Limitations Hemolysis in whole blood specimen will interfere with results. Multiple freeze
thaw cycles and sample storage above refrigerated temperatures will interfere
with proper nucleic acid extraction. If a specimen is drawn at convalescence it
will reduce the chance of the target organism being present in blood. Avoid
collection of blood specimen in heparin tubes.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-0152
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 102 of 363


Test Order
Ehrlichia Serology
CDC-10311

Synonym(s) Human monocytic ehrlichiosis


Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped refrigerated on cold packs.
Requirements
Methodology Indirect Fluorescence Assay (IFA)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact laboratory prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 103 of 363


Test Order
Ehrlichia Special Study
CDC-10498

Synonym(s) Human monocytic ehrlichiosis and HME


Pre-Approval Needed Kato, Cecilia, (404) 639-0152, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Molecular detection, Serology, Culture, Immunohistochemistry (IHC), Other
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cecilia Kato
(404) 639-0152
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 104 of 363


Test Order
Entamoeba histolytica/dispar Molecular Detection
CDC-10478

Synonym(s) Amebiasis, Entameba histolytica, Entameba dispar, parasite


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Stool, liver aspirate


Type for Testing
Minimum Volume Required 0.5 g or 0.5 ml

Storage & Preservation of Specimens collected in the absence of preservatives must be kept refrigerated (4
Specimen Prior to Shipping C) or frozen. Stool samples in a PCR-compatible fixative, e.g. TotalFix, UniFix,
EcoFix and modified PVA (Zn- or Cu-based), can be kept at room temperature.
Alternatively stool specimens can also be mixed in potassium dichromate 2.5%
(1:1 dilution) or in absolute ethanol (1:1 dilution).
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship
Include Specimen Handling fixed/preserved specimens at room temperature. Ship unpreserved specimens
Requirements on wet ice (cold pack) if stored refrigerated or frozen (on dry ice) if stored
frozen.
Methodology Real-Time PCR
Turnaround Time 21 Days
Interferences & Limitations Specimens fixed in formalin-containing preservatives or LV-PVA are not suitable
for molecular studies.
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Theresa Benedict
(404) 718-4124
tgd5@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 105 of 363


Test Order
Enteric Isolation - Primary Specimen
CDC-10106

Synonym(s) Enteric Pathogen Culture


Pre-Approval Needed Martin, Haley, (404) 639-1612, hvw0@cdc.gov
Fitzgerald, Collette, (404) 639-0838, chf3@cdc.gov
Supplemental Information Consult with EDLB contact before sending specimens. Targeted organisms
Required include: Salmonella, Shigella, Campylobacter, STEC, pathogenic
Enterobacteriaceae, Listeria, Vibrio , Cronobacter, and related foodborne and
waterborne pathogens. Provide any preliminary results available.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Specimens that are acceptable will be determined upon consultation. Targeted
Type for Testing organisms include: Salmonella, Shigella, Campylobacter, STEC, pathogenic
Enterobacteriaceae, Listeria, Vibrio, Cronobacter, and related foodborne and
waterborne pathogens.
Minimum Volume Required Not Applicable

Storage & Preservation of Storage and preservation are dependent upon consultation
Specimen Prior to Shipping

Transport Medium Transport medium is dependent upon consultation


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Specifics of shipping will depend upon consultation
Methodology Enrichment, Isolation, Phenotypic Identification (Serotyping), PCR testing for
virulence markers
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Haley Martin
(404) 639-1612
hvw0@cdc.gov
Collette Fitzgerald
(404) 639-0838
chf3@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 106 of 363


Test Order
Enteric Special Study
CDC-10512

Synonym(s) none
Pre-Approval Needed Huang, Andrew, (404) 639-1545, wwm8@cdc.gov
Williams-Newkirk, A.Jo, (404) 639-1087, lgy7@cdc.gov
Supplemental Information Notify POCs before sending specimens and send study-specific datasheet.
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Stool or pathogen isolate


Type for Testing
Minimum Volume Required Stool: 4ml unless lower volume preapproved; pathogen isoloate: n/a

Storage & Preservation of Stool specimens must be frozen at -70C or lower upon receipt by the
Specimen Prior to Shipping submitting laboratory and held at that temperature until shipment to CDC

Transport Medium Stool: none or Cary Blair; Pathogen isolate: pathogen-appropriate agar in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Specimens must be labeled with one of the anonymized sample identifier
stickers provided to study participants. No personally identifiable information
can be present on the sample or accompanying documentation.
Shipping Instructions which Stool samples must be shipped on dry ice. Ship pathogen isolates at ambient
Include Specimen Handling temperature. All samples must be packaged in accordance with all applicable
Requirements state and federal regulations. Ship only Monday Thursday overnight to avoid
weekend deliveries.
Methodology
Turnaround Time
Interferences & Limitations n/a
Additional lnformation This test is for the submission of samples to participate in an enteric pathogen special study. No
results of testing will be reported back to submitters.
CDC Points of Contact Andrew Huang
(404) 639-1545
wwm8@cdc.gov
A.Jo Williams-Newkirk
(404) 639-1087
lgy7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 107 of 363


Test Order
Enterovirus Detection and Identification
CDC-10312

Synonym(s) Enterovirus (EV), coxsackieviruses (CVA) (CVB), Echovirus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Specimens include stool, serum, throat or nasal swab, cerebrospinal fluid (CSF),
Type for Testing vesicle fluid or lesion, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs.
Fresh or frozen tissues are preferred to Formalin fixed tissues, but will accept
both.
Minimum Volume Required Not Applicable

Storage & Preservation of Vesicle fluid, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs:
Specimen Prior to Shipping Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays. Place the swab immediately into a sterile viral containing 2mL of viral
transport media without antibiotics, if possible.

Stool: Collect in a clean, dry, leak-proof container.

Serum: For each serum specimen, collect whole blood into a serum separator
tube (marble or tiger top SST). Allow to clot at room temperature for a minimum
of 30 minutes and centrifuge.
Transport Medium Viral transport medium. If you do not have viral transport media, place the swab
into a sterile vial without viral transport media. Aseptically, cut or break
applicator sticks off near the tip to permit tightening of the cap. For NP/OP
swabs, both swabs can be placed in the same vial, if desired.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.

Include the full name, title, complete mailing address, email address, telephone,
and fax number of the submitter. This will be the person to whom the final
report will be mailed to.
Methodology Molecular techniques
Turnaround Time 14 Days
Interferences & Limitations Collecting specimens during the first week of illness is ideal although the virus
can be shed in stool for several weeks. A specimen set collected in the second
week of illness should include a rectal swab or stool sample.
Additional lnformation Minimum volume for cell culture is 0.5-1 mL, for CSF is 60 uL, and for fresh
frozen tissues is 2 mm^2.

Stool: Stool may be collected within 14 days of symptom onset. Collect 10-20 g
of stool in a clean, dry, leak-proof container.

Tuesday, November 29, 2016 Version: 1.1 Page 108 of 363


Test Order
Enterovirus Detection and Identification
CDC-10312

Serum: For each serum specimen, collect (adults and children > 6kg: 5 mL,
children <6kg: 2 mL) of whole blood into a serum separator tube (marble or tiger
top SST). A minimum of 1 mL of whole blood is needed for testing of pediatric
patients. Allow to clot at room temperature for a minimum of 30 minutes and
centrifuge.
CDC Points of Contact Alan Nix
(404) 639-1689
wbn0@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 109 of 363


Test Order
Entomology Special Study
CDC-10494

Synonym(s) None
Pre-Approval Needed Lawrence, Gena, (404) 718-4315, geg7@cdc.gov
Sutcliffe, Alice, (404) 718-4326, gok0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Animal

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Gena Lawrence
(404) 718-4315
geg7@cdc.gov
Alice Sutcliffe
(404) 718-4326
gok0@cc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 110 of 363


Test Order
Environmental Microbiology Study
CDC-10232

Synonym(s) None
Pre-Approval Needed Noble-Wang, Judith, (404) 639-2321, cux2@cdc.gov
O'Connell, Heather, (404) 639-4864, ftw2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Judith Noble-Wang
(404) 639-2321
cux2@cdc.gov
Heather O'Connell
(404) 639-4864
ftw2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 111 of 363


Test Order
Epstein Barr Virus (EBV) Detection
CDC-10265

Synonym(s) EBV
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Saliva, cerebrospinal fluid (CSF) or blood


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes.

Transport Medium Not Applicable


Specimen Labeling Provide a specimen ID. Do not send specimen labeled with patients name.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 112 of 363


Test Order
Escherichia and Shigella Identification, Serotyping, and
Virulence Profiling
CDC-10114
Synonym(s) None
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens; Please call for approval
Required prior to sending other specimen types.

Provide any preliminary results available


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Store and ship isolates at ambient temperatures not to exceed 35C or at 4C.
Specimen Prior to Shipping Isolates held for more than a month should be frozen.

Ship in compliance with Federal and local guidelines. Shiga toxin-positive


bacteria should be shipped as Category A Infectious Substances.
Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements Ship at ambient temperature in compliance with Federal and local guidelines.
Shiga toxin-positive bacteria should be shipped as Category A Infectious
Substances.

There are no time constraints for submitting sequence data


Methodology Phenotypic Identification, Genetic Identification, Serotyping and Virulence
Profiling, PCR for STEC and other pathotype-specific virulence genes
Turnaround Time 8 Weeks
Interferences & Limitations Virulence and serotype modification genes encoded by mobile genetic elements
(bacteriophages, plasmids and pathogenicity islands) may be spontaneously lost
during transit and storage. Conditions that induce a stress response in the
bacterium can affect the stability of virulence factors.
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form. Epidemiologic metadata, PulseNet cluster code, and PFGE pattern
designation requested if available.

Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Nancy Strockbine
(404) 639-4186
nas6@cdc.gov
Devon Stripling
(404) 639-2251
euo4@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 113 of 363


Test Order
Escherichia and Shigella Study
CDC-10115

Synonym(s) None
Pre-Approval Needed Strockbine, Nancy, (404) 639-4186, nas6@cdc.gov
Stripling, Devon, (404) 639-2251, euo4@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen As directed by study protocol


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Ship as directed by study protocol in compliance with Federal and local
Specimen Prior to Shipping guidelines. Shiga toxin-positive bacteria should be shipped as Category A
Infectious Substances.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight growth on nonselective slant/stab such as TSA, HIA, etc.; screw
Include Specimen Handling cap tubes preferred or as directed by the study protocol.
Requirements
Methodology
Turnaround Time
Interferences & Limitations Virulence and serotype modification genes encoded by mobile genetic elements
(bacteriophages, plasmids and pathogenicity islands) may be spontaneously lost
during transit and storage. Conditions that induce a stress response in the
bacterium can affect the stability of virulence factors.
Additional lnformation None
CDC Points of Contact Nancy Strockbine
(404) 639-4186
nas6@cdc.gov
Devon Stripling
(404) 639-2251
euo4@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 114 of 363


Test Order
Escherichia coli (STEC) serology (not serotyping)
CDC-10452

Synonym(s) Enteric Pathogen


Pre-Approval Needed Aubert, Rachael, (404) 639-3816, vrl7@cdc.gov
Korth, Michael, (404) 639-2099, mqk8@cdc.gov
Supplemental Information Date of illness onset, date of serum collection, clinical diagnosis. Indicate if
Required patient has HUS and onset date. If patient has undergone plasmaphoresis
indicate date on submission form.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired serum is preferred. Serum is always preferred but plasma is acceptable.
Type for Testing Do not pool specimens.
Minimum Volume Required 100 uL (More Preferred)

Storage & Preservation of Maintain serum at 4C (preferred); frozen specimens acceptable.


Specimen Prior to Shipping

Transport Medium Separate serum from the clot and ship in a sterile labeled tube with the top
tightly closed
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Rachael Aubert (vrl7@cdc.gov, (404) 639-3816) once specimens have been
Requirements shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology EIA
Turnaround Time 3 Months
Interferences & Limitations None
Additional lnformation Paired serum specimens always preferred.

Please send one tube per specimen submission form. Submit multiple forms if
needed.
CDC Points of Contact Rachael Aubert
(404) 639-3816
vrl7@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 115 of 363


Test Order
Escherichia coli and Shigella Subtyping
CDC-10116

Synonym(s) E. coli Typing, Shigella Typing


Pre-Approval Needed None
Supplemental Information Isolates should be identified to the species level by the sender. Provide any
Required preliminary results available. Indicate subtyping method(s) requested on
specimen submission form
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Store isolates at ambient temperatures not to exceed 35C or at 4C. Isolates
Specimen Prior to Shipping held for more than a month should be frozen

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements Ship at ambient temperature in compliance with Federal and local guidelines.
Shiga toxin-positive bacteria should be shipped as Category A Infectious
Substances.

There are no time constraints for submitting sequence data


Methodology Phenotypic Serotyping, Genetic Serotyping, Virulence Profiling, AST, PFGE, MLVA
Turnaround Time 8 Weeks
Interferences & Limitations Virulence and serotype modification genes encoded by mobile genetic elements
(bacteriophages, plasmids and pathogenicity islands) may be spontaneously lost
during transit and storage. Conditions that induce a stress response in the
bacterium can affect the stability of virulence factors and may affect the
expression of O and H antigens.
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form. Epidemiologic metadata, PulseNet cluster code, and PFGE pattern
designation requested if available.

Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Nancy Strockbine
(404) 639-4186
nas6@cdc.gov
Devon Stripling
(404) 639-2251
euo4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 116 of 363


Test Order
Fascioliasis Serology
CDC-10505

Synonym(s) Fascioliasis, Fasciola hepatica, liver fluke


Pre-Approval Needed DPDM Public Inquiries, , (404) 718-4745, parasites@cdc.gov
DPDx, , , dpdx@cdc.gov
Supplemental Information Please contact Public Inquiries at the Division of Parasitic Diseases and Malaria
Required at phone number (404)718-4745 or at Parasites@cdc.gov to get pre-approval
to order the Fascioliasis serology.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and plasma


Type for Testing
Minimum Volume Required 2.0 ml

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice
Requirements
Methodology Immunoblot, Western blot, Antibody detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids and
hemoglobin
Additional lnformation none
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 117 of 363


Test Order
Filariasis Serology
CDC-10462

Synonym(s) Brugia malayi, Wuchereria bancrofti; Bancroftian filariasis, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology EIA, ELISA, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 118 of 363


Test Order
Francisella tularensis Culture and Identification
CDC-10313

Synonym(s) Tularemia
Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Human: lymph node aspirate, sputum, bronchial/tracheal wash, pleural fluid,
Type for Testing blood, ulcer swab, biopsy/autopsy specimens (sections of lymph node, lung,
liver, spleen); Animal: Necropsy specimen (lymph node, lung, liver or spleen).
Minimum Volume Required Not Applicable

Storage & Preservation of Store specimens containing suspected live bacteria at 2-8C to maintain
Specimen Prior to Shipping viability. If processing is delayed, tissue samples can be directly frozen at -70C.
Store samples for culture of live bacteria without preservatives (formaldehyde,
alcohol), at 2-8C (not frozen). Anticoagulants such as heparin, citrate and EDTA
are acceptable because they do not inhibit the viability of bacteria.
Transport Medium Respiratory specimens, lymph node aspirates, blood,
tissue/biopsy/autopsy/necropsy specimens should all be transported at 4C.
Swabs must be in a Cary-Blair or Amies medium, not frozen. If tissue
biopsy/autopsy/necropsy transport is delayed, tissue samples can be directly
frozen at -70C.
Specimen Labeling Specimen identifier and patient name
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Culture, Direct Fluorescent Antibody (DFA), Biochemical subtyping
Turnaround Time 3 Weeks
Interferences & Limitations Samples for testing by culture should be taken prior to antibiotic treatment
Additional lnformation None
CDC Points of Contact Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov
Marty Schriefer
(970) 221-6479
mms7@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 119 of 363


Test Order
Francisella tularensis Serology
CDC-10314

Synonym(s) Tularemia
Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 500 uL

Storage & Preservation of Sera may be stored at 2-8C for up to 14 days. If testing is delayed for a longer
Specimen Prior to Shipping period, serum samples may be frozen.

Transport Medium Not Applicable


Specimen Labeling Specimen identifier and patient name
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Microagglutination
Turnaround Time 2 Weeks
Interferences & Limitations Hemolyzed samples interfere with test results
Additional lnformation None
CDC Points of Contact Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov
Marty Schriefer
(970) 221-6479
mms7@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 120 of 363


Test Order
Francisella tularensis Special Study
CDC-10315

Synonym(s) None
Pre-Approval Needed Petersen, Jeannine, (970) 266-3524, nzp0@cdc.gov
Schriefer, Marty, (970) 221-6479, mms7@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov
Marty Schriefer
(970) 221-6479
mms7@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 121 of 363


Test Order
Fungal Identification
CDC-10179

Synonym(s) Fungal identification, mold identification, yeast identification


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Isolates can be refrigerated or kept at an ambient temperature


Specimen Prior to Shipping

Transport Medium Isolates should be on a suitable agar slant


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Specimen should be shipped at ambient temperature
Methodology Phenotypic Testing, DNA Sequencing
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov
Mark Lindsley
(404) 639-4340
mil6@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 122 of 363


Test Order
Fungal Serology - Basidiobolus
CDC-10183

Synonym(s) Fungal serology; fungal complement fixation; fungal immunodiffusion


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum; Plasma is not accepted


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimens should be kept either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen at 4C should be shipped on cold packs
Frozen specimen should be shipped on dry ice
Methodology Immunodiffusion
Turnaround Time 2 Weeks
Interferences & Limitations Hemolysis and lipidemia may interfere with the test results
Additional lnformation Serum should be prepared as soon as possible after drawing blood to prevent
hemolysis
CDC Points of Contact Mark Lindsley
(404) 639-4340
mil6@cdc.gov
Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 123 of 363


Test Order
Fungal Serology - Histoplasma, Blastomyces, Coccidioides
CDC-10180

Synonym(s) Fungal serology, fungal complement fixation, fungal immunodiffusion


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum; CSF. Plasma is not accepted


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimens should be kept either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen at 4C should be shipped on cold packs
Frozen specimen should be shipped on dry ice
Methodology Complement Fixation, Immunodiffusion
Turnaround Time 4 Weeks
Interferences & Limitations Hemolysis and lipidemia may interfere with the test results
Additional lnformation Serum should be prepared as soon as possible after drawing blood to prevent
hemolysis
CDC Points of Contact Mark Lindsley
(404) 639-4340
mil6@cdc.gov
Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 124 of 363


Test Order
Fungal Serology - Paracoccidioides
CDC-10184

Synonym(s) Fungal serology; fungal complement fixation; fungal immunodiffusion


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum; Plasma is not accepted


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimens should be kept either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen at 4C should be shipped on cold packs
Frozen specimen should be shipped on dry ice
Methodology Complement Fixation, Immunodiffusion
Turnaround Time 4 Weeks
Interferences & Limitations Hemolysis and lipidemia may interfere with the test results
Additional lnformation Serum should be prepared as soon as possible after drawing blood to prevent
hemolysis
CDC Points of Contact Mark Lindsley
(404) 639-4340
mil6@cdc.gov
Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 125 of 363


Test Order
Fungal Serology - Sporothrix
CDC-10182

Synonym(s) Fungal serology, fungal complement fixation, fungal immunodiffusion, latex


agglutination for Sporothrix
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum; CSF. Plasma is not accepted


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of Specimens should be kept either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen at 4C should be shipped on cold packs
Frozen specimen should be shipped on dry ice
Methodology Complement Fixation, Immunodiffusion, Latex Agglutination
Turnaround Time 2 Weeks
Interferences & Limitations Hemolysis and lipidemia may interfere with the test results
Additional lnformation Serum should be prepared as soon as possible after drawing blood to prevent
hemolysis
CDC Points of Contact Mark Lindsley
(404) 639-4340
mil6@cdc.gov
Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 126 of 363


Test Order
Fungal Study
CDC-10181

Synonym(s) None
Pre-Approval Needed Lockhart, Shawn, (404) 639-2569, gyi2@cdc.gov
Lindsley, Mark, (404) 639-4340, mil6@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Not Applicable


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation None
CDC Points of Contact Shawn Lockhart
(404) 639-2569
gyi2@cdc.gov
Mark Lindsley
(404) 639-4340
mil6@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 127 of 363


Test Order
Gastroenteritis Virus Special Study
CDC-10316

Synonym(s) None
Pre-Approval Needed Vinje, Jan, (404) 639-3721, ahx8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jan Vinje
(404) 639-3721
ahx8@cdc.gov
Leslie Barclay
(404) 639-1159
gvm3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 128 of 363


Test Order
Genital Ulcer Disease (Syphilis, Chancroid, Herpes) Molecular
Detection
CDC-10174
Synonym(s) GUD
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Ulcer swabs, FFPE tissues or frozen tissues, and aspirates from ulcer or buboes
Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of FFPE can be kept at room temperature and swabs and other specimens should be
Specimen Prior to Shipping kept frozen

Transport Medium Nucleic Acid Amplification Test (NAAT) commercial transport medium, PBS,
Saline or TRIS buffer
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship FFPE at
Include Specimen Handling room temperature and frozen specimen should be shipped on dry ice, as an
Requirements etiologic agent.
Methodology PCR
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Cheng Chen
(404) 639-3154
cyc1@cdc.gov
Kai Chi
(404) 639-0694
krc2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 129 of 363


Test Order
Gram Negative Bacillus (Non-enteric/Nonfermenter) ID
CDC-10135

Synonym(s) GNR, Gram Negative Rod


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 130 of 363


Test Order
Gram Negative Coccus (Not GC or meningococcus) ID
CDC-10138

Synonym(s) Neisseria Identification, GNC


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 131 of 363


Test Order
Gram Positive Bacillus ID
CDC-10137

Synonym(s) Gram Positive Rod Identification, GPB, GPR


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 132 of 363


Test Order
Haemophilus ducreyi Molecular Detection
CDC-10511

Synonym(s) GUD
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Ulcer swabs, FFPE tissues or frozen tissues, and aspirates from ulcer or buboes
Type for Testing
Minimum Volume Required n/a

Storage & Preservation of FFPE can be kept at room temperature and swabs and other specimens should be
Specimen Prior to Shipping kept frozen

Transport Medium Nucleic Acid Amplification Test (NAAT) commercial transport medium, PBS, saline
or TRIS buffer
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship FFPE at
Include Specimen Handling room temperature and frozen specimen should be shipped on dry ice, as an
Requirements etiologic agent.
Methodology PCR
Turnaround Time 2 Weeks
Interferences & Limitations none
Additional lnformation none
CDC Points of Contact Cheng Chen
(404) 639-3154
cyc1@cdc.gov
Kai Chi
(404) 639-0694
krc2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 133 of 363


Test Order
Haemophilus influenzae Identification and Serotyping
CDC-10221

Synonym(s) H. influenzae ID and SAST, H. flu, Hi


Pre-Approval Needed None
Supplemental Information If tested and known, please include lab results with methods used (including
Required manufacturer of antiserum) in previous lab results section of submission form
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolate, frozen stock, primary specimen such as CSF, whole blood,
Type for Testing serum, and other sterile site specimen types upon consultation.
Minimum Volume Required 0.25 mL

Storage & Preservation of Primary specimens or stocks should be kept frozen. After overnight incubation
Specimen Prior to Shipping at 37C with 5% CO2, store slants at an ambient temperature

Transport Medium Preferred medium include chocolate agar slants or frozen stocks. If possible, for
the shipment of 10 or more specimens, please ship frozen stocks.
Specimen Labeling Tests subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition. Label ABCs/Enhanced Surveillance specimens
with the state ID & accession number.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Frozen specimens should be shipped on dry ice. Please include shipping
spreadsheet in shipment and if possible, email spreadsheet prior to shipment.
Methodology Growth, Morphology, Biochemical Testing, Slide Agglutination Serotyping, Real-
time PCR
Turnaround Time 30 Days
Interferences & Limitations Improperly temperature controlled specimens/isolates can give false negative
results.
Additional lnformation Turnaround time: 30 days for real-time PCR testing of clinical specimens; 90
days for testing of enhanced surveillance submissions
CDC Points of Contact Melissa Whaley Meningitis Laboratory
(404) 639-3920 (404) 639-5009
dbq3@cdc.gov
Laurel T. Jenkins
(404) 639-1340
knt9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 134 of 363


Test Order
Haemophilus influenzae Study
CDC-10222

Synonym(s) Hi Study
Pre-Approval Needed Wang, Xin, (404) 639-5474, gqe8@cdc.gov
Briere, Elizabeth, (404) 639-0732, ejc0@cdc.gov
Supplemental Information Brief description of study or surveillance program.
Required
Supplemental Form Required: CDC Meningitis Laboratory: Molecular Typing
Request Submission Form (provided upon request by CDC Meningitis
Laboratory).

Supplemental Form
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolate or frozen stock.


Type for Testing
Minimum Volume Required N/A

Storage & Preservation of Primary specimens or stocks should be kept frozen. After overnight incubation at
Specimen Prior to Shipping 37C with 5% CO2, store slants at an ambient temperature.

Transport Medium Chocolate agar slants or frozen stocks.


Specimen Labeling Tests subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Frozen specimens should be shipped on dry ice. Please include shipping
spreadsheet in shipment and if possible, email spreadsheet prior to shipment.
Methodology Multilocus Sequence Typing (MLST), Whole genome sequencing (WGS)
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Xin Wang
(404) 639-5474
gqe8@cdc.gov
Melissa Whaley
(404) 639-3920
dbq3@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 135 of 363


Test Order
Haemophilus species (Not H. influenzae/H. ducreyi) ID
CDC-10141

Synonym(s) None
Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Biochemical analysis Primary Culture based on specimen type, MALDI-TOF, 16S
sequence based identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 136 of 363


Test Order
Hantavirus (No. American) Identification
CDC-10319

Synonym(s) Hanta, HPS, HFRS


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 137 of 363


Test Order
Hantavirus (So. American) Identification
CDC-10320

Synonym(s) Hanta, HPS, HFRS


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Testing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 138 of 363


Test Order
Hantavirus Serology
CDC-10321

Synonym(s) Hanta, HPS, HFRS, Hantaan


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations None
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 139 of 363


Test Order
Healthcare-associated Outbreak Identification and Typing
CDC-10162

Synonym(s) Healthcare Outbreak or Nosocomial Outbreak


Pre-Approval Needed Noble-Wang, Judith, (404) 639-2321, cux2@cdc.gov
Moulton-Meissner, Heather, (404) 639-4864, ftw2@cdc.gov
Supplemental Information Supplemental Line List required contact laboratory for more information
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolates and primary environmental specimen (swabs, wipes, water
Type for Testing and other fluids, medical devices). In addition, fluids and products used for
patient care.
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen at a refrigerated temperature until ready for shipping
Specimen Prior to Shipping

Transport Medium Use an agar slant not a agar plate for isolates
Specimen Labeling No patient identifiers. Please include specimen identifiers on Line List
Shipping Instructions which Ship isolates at ambient temperatures and ship environmental specimens on
Include Specimen Handling cold-packs. Ship overnight, Monday through Thursday, for delivery within 24
Requirements hours of collection.
Methodology Phenotypic and Molecular Identification, PFGE, Culture, Other
Turnaround Time 3 Weeks
Interferences & Limitations Holding environmental samples at room temperature >1 hour after collection
may decrease recovery. Neutralization of chlorine residual in potable water is
necessary during collection.
Additional lnformation Turnaround time for nontuberculosis mycobacteria may take up to 8 weeks.

Criteria for submission:


-Prior consultation with CDC/DHQP Prevention and Response Branch on
epidemiological investigation. Contact info: haioutbreak@cdc.gov or
404-639-4000.
-If healthcare facility will be submitting samples directly to CDC they must
receive prior approval from State Health Department. Provide State Health
Department contact information.
-For isolate submission, include the test method that was used to identify the
specimen in the "Previous Laboratory Results/Comments" section.
CDC Points of Contact Heather Moulton-Meissner
(404) 639-4864
ftw2@cdc.gov
Judith Noble-Wang
(404) 639-2321
cux2@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 140 of 363


Test Order
Helicobacter pylori Special Study
CDC-10117

Synonym(s) None
Pre-Approval Needed Rudolph, Karen, (907) 729-3454, kmr2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Gastric biopsy


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of Store at -70C


Specimen Prior to Shipping

Transport Medium Cysteine Freeze media


Specimen Labeling Specimen ID number and area of stomach e.g. antrum or fundus
Shipping Instructions which Ship on dry ice
Include Specimen Handling
Requirements
Methodology Culture
Turnaround Time 15 Days
Interferences & Limitations To be determined
Additional lnformation Please provide shipping information to CDC Points of Contact prior to shipping
specimens
CDC Points of Contact Karen Rudolph
(907) 729-3454
kmr2@cdc.gov
Julie Morris
(907) 729-3445
zbf2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 141 of 363


Test Order
Hendra Serology
CDC-10324

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 142 of 363


Test Order
Hepatitis A Serology, NAT and Genotyping
CDC-10325

Synonym(s) HAV, Hepatitis A virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA plasma, stool


Type for Testing
Minimum Volume Required 1.5 mL

Storage & Preservation of Specimens should be stored frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Methodology Total anti-HAV by Chemiluminescence, IgM anti-HAV by Chemiluminescence,
HAV RNA, HAV Genotyping by NAT P2B Sequencing
Turnaround Time 1 Week
Interferences & Limitations Hemolyzed specimen are not accepted
Additional lnformation NAT based assays and genotyping may take up to 3 weeks for turn around time
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 143 of 363


Test Order
Hepatitis B Serology, NAT and Genotyping
CDC-10326

Synonym(s) HBV, Hepatitis B virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA plasma.


Type for Testing Note: For Quantitative anti-HBs test - Serum only
Minimum Volume Required 2 mL

Storage & Preservation of Specimens should be stored frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Methodology HBsAg by EIA, IgM anti-HBc by Chemiluminescence, Total anti-HBc by
Chemiluminescence, Anti-HBs by Chemiluminescence, HBeAg by
Chemiluminescence, Anti-Hbe by EIA, HBV DNA by TaqMan IVD, HBV Genotyping
by NAT S Gene Sequencing
Turnaround Time 1 Week
Interferences & Limitations Hemolyzed specimen are not accepted
Additional lnformation NAT based assays and genotyping may take up to 3 weeks for turn around time
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 144 of 363


Test Order
Hepatitis B Surface Antigen Confirmatory Test
CDC-10451

Synonym(s) HBV, Hepatitis B virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA Plasma


Type for Testing
Minimum Volume Required 300uL

Storage & Preservation of Specimens should be stored frozen at -20C


Specimen Prior to Shipping

Transport Medium None


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on cold packs
Methodology Neutralization
Turnaround Time 10 Days
Interferences & Limitations Do not send whole blood or hemolyzed serum
Additional lnformation None
CDC Points of Contact Jan Drobenuic
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 145 of 363


Test Order
Hepatitis C Serology, NAT and Genotyping
CDC-10327

Synonym(s) HCV, Hepatitis C virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA Plasma


Type for Testing
Minimum Volume Required 2 mL

Storage & Preservation of Specimens should be stored frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Methodology Anti-HCV by Chemiluminescence, HCV RNA by TaqMan IVD, HCV Genotyping by
NAT NS5B Gene Sequencing
Turnaround Time 1 Week
Interferences & Limitations Hemolyzed specimen are not accepted
Additional lnformation NAT based assays and genotyping may take up to 3 weeks for turn around time
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 146 of 363


Test Order
Hepatitis D Serology, NAT and Genotyping
CDC-10328

Synonym(s) HDV, Hepatitis D virus


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA Plasma


Type for Testing
Minimum Volume Required 2 mL

Storage & Preservation of Specimens should be stored frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Methodology Total anti-HDV by EIA, HDV RNA by Real Time qRT-PCR, HDV Genotyping by
direct sequence analysis
Turnaround Time 2 Weeks
Interferences & Limitations Hemolyzed specimen are not accepted
Additional lnformation NAT based assays and genotyping may take up to 3 weeks for turn around time
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 147 of 363


Test Order
Hepatitis E Serology, NAT and Genotyping
CDC-10329

Synonym(s) HEV, Hepatitis E virus


Pre-Approval Needed Drobeniuc, Jan, (404) 639-3790, jqd6@cdc.gov
Kamili, Saleem, (404) 639-4431, sek6@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/hepatitis/HEV/LabTestingRequests.htm
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, EDTA plasma, and stool


Type for Testing
Minimum Volume Required 2 mL

Storage & Preservation of Specimens should be stored frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Methodology IgM anti-HEV by EIA, IgG anti-HEV by EIA, HEV RNA by Real Time qRT-PCR, HEV
Genotyping by direct sequence analysis
Turnaround Time 2 Weeks
Interferences & Limitations Hemolyzed specimen are not accepted
Additional lnformation NAT based assays and genotyping may take up to 3 weeks for turn around time
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 148 of 363


Test Order
Hepatitis Outbreak Investigation
CDC-10330

Synonym(s) HAV, HBV, HCV, HDV, HEV, Hepatitis A virus, Hepatitis B virus, Hepatitis C virus,
Hepatitis D virus, Hepatitis E virus
Pre-Approval Needed Drobeniuc, Jan, (404) 639-3790, jqd6@cdc.gov
Kamili, Saleem, (404) 639-4431, sek6@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Not Applicable


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which None
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 149 of 363


Test Order
Hepatitis Special Study
CDC-10331

Synonym(s) None
Pre-Approval Needed Drobeniuc, Jan, (404) 639-3790, jqd6@cdc.gov
Kamili, Saleem, (404) 639-4431, sek6@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which None
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jan Drobeniuc
(404) 639-3790
jqd6@cdc.gov
Saleem Kamili
(404) 639-4431
sek6@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 150 of 363


Test Order
Herpes Simplex Virus / Detection
CDC-10258

Synonym(s) Oral herpes, Genital herpes


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Skin lesion, cerebrospinal fluid (CSF) or saliva


Type for Testing
Minimum Volume Required 200 uL (saliva)

Storage & Preservation of Skin lesions should be kept dry and saliva can be kept either refrigerated or
Specimen Prior to Shipping frozen.

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight on cold packs or dry ice. Skin
Include Specimen Handling lesions should be shipped dry. Ship as an etiologic agent.
Requirements See standard shipping instructions for biologic agent
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 151 of 363


Test Order
Herpes Simplex Virus / Serology
CDC-10259

Synonym(s) Oral herpes, Genital herpes


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, plasma, or cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen.


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology IgG antibody detected by EIA
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 152 of 363


Test Order
Herpesvirus Encephalitis Panel
CDC-10262

Synonym(s) None
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Cerebrospinal fluid (CSF), saliva, whole blood, or skin lesions
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes. Skin lesions should be kept dry.

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight Monday Thursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR) for VZV, Polymerase Chain Reaction (PCR) for
HSV1, Polymerase Chain Reaction (PCR) for HSV2, Polymerase Chain Reaction
(PCR) for EBV, Polymerase Chain Reaction (PCR) for HHV6
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 153 of 363


Test Order
Herpesvirus Special Study
CDC-10270

Synonym(s) None
Pre-Approval Needed Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 154 of 363


Test Order
HIV antigen/antibody Combo
CDC-10485

Synonym(s) None
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or Plasma


Type for Testing
Minimum Volume Required 1mL

Storage & Preservation of 2 days at ambient temperature; 7 days at 2-8C. Specimens should be stored
Specimen Prior to Shipping at -20C for long-term storage and should not have more than 4 freeze/thaw
cycles.
Transport Medium
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which For best results, specimens should be shipped frozen on dry ice for overnight
Include Specimen Handling delivery to the HIV reference laboratory.
Requirements
Methodology EIA
Turnaround Time 21 Days
Interferences & Limitations Do not heat inactivate specimens
Additional lnformation None
CDC Points of Contact Timothy Granade
(404) 639-3850
txg1@cdc.gov
Bill Switzer
(404) 639-0219
bis3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 155 of 363


Test Order
HIV Molecular Surveillance Study (International Only)
CDC-10332

Synonym(s) None
Pre-Approval Needed Yang, Chunfu, (404) 639-4975, cxy0@cdc.gov
DeVos, Joshua, (404) 639-5442, ext8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Chunfu Yang (Primary POC)
(404) 639-4975
cxy0@cdc.gov
Joshua DeVos (Secondary POC)
(404) 639-5442
ext8@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 156 of 363


Test Order
HIV Serology NHANES
CDC-10279

Synonym(s) HIV ELISA, HIV antibody


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and/or plasma. The following anticoagulants are acceptable: EDTA,
Type for Testing sodium citrate, CPD, CPDA-1, and ACD. SST and PPT are also acceptable.
Minimum Volume Required 1 mL

Storage & Preservation of Specimens may be stored at 2-8C for 7 days. Long-term storage should be
Specimen Prior to Shipping at -20C or colder and specimens should not have incurred more than 5 freeze-
thaw cycles.
Transport Medium Not Applicable
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Enzyme-linked Immunosorbent Assay (ELISA), Western Blot, Rapid Test
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Tim Granade
(404) 639-3850
txg1@cdc.gov
Bill Switzer
(404) 639-0219
bis3@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 157 of 363


Test Order
HIV Serology Study (International Only)
CDC-10333

Synonym(s) None
Pre-Approval Needed Parekh, Bharat, (404) 639-3647, bsp1@cdc.gov
Kalou, Mireille, (404) 639-2794, chn7@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Bharat Parekh
(404) 639-3647
bsp1@cdc.gov
Mireille Kalou
(404) 639-2794
chn7@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 158 of 363


Test Order
HIV Special Study
CDC-10278

Synonym(s) None
Pre-Approval Needed Switzer, Bill, (404) 639-0219, bis3@cdc.gov
Granade, Tim, (404) 639-3850, txg1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Bill Switzer
(404) 639-0219
bis3@cdc.gov
Tim Granade
(404) 639-3850
txg1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 159 of 363


Test Order
HIV- Drug Resistance Special Study (International Only)
CDC-10334

Synonym(s) None
Pre-Approval Needed Yang, Chunfu, (404) 639-4975, cxy0@cdc.gov
DeVos, Joshua, (404) 639-5442, ext8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Chunfu Yang (Primary POC)
(404) 639-4975
cxy0@cdc.gov
Joshua DeVos (Secondary POC)
(404) 639-5442
ext8@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 160 of 363


Test Order
HIV- Genotype Drug Resistance (International Only)
CDC-10335

Synonym(s) HIV DR, HIV, HIV Sequencing, HIV Susceptibility


Pre-Approval Needed Yang, Chunfu, (404) 639-4975, cxy0@cdc.gov
DeVos, Joshua, (404) 639-5442, ext8@cdc.gov
Supplemental Information Specimens must be accompanied with complete requisition form(s).
Required
Plasma or Serum:
CDC Form 0.753: Application for Permit to Import or
Transport Etiological Agents, Hosts, or Vectors of Human Disease and
Requisition Form

Dried Blood Spots:


Requisition Form
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Plasma, serum, and dried blood spots (DBS). Dried blood spots should be least 4
Type for Testing saturated 13mm circles (preferably 5) containing 100 L of whole blood.
Minimum Volume Required 1 mL (Plasma or Serum)

Storage & Preservation of For plasma or serum keep frozen at -65C to -80C for 6 months. Use the
Specimen Prior to Shipping appropriate anticoagulant (EDTA).

Dried blood spots should be kept at an ambient temperature (15-35C) for


testing performed within 14 days and frozen at -70C or colder if testing is not
performed within 14 days.
Transport Medium Plasma or serum should be transported in a 1.5 - 2.0 mL polypropylene tube
with screw cap and O-ring. Transport specimens in frozen conditions using dry
ice or liquid nitrogen. Dried blood spots should each be wrapped with a folded
sheet of glassine paper. Stack 5-10 glassine paper-wrapped cards into a gas-
impermeable, sealable, plastic bag containing 5-10 desiccant packs to remove
residual moisture along with one humidity indicator card. Ensure the specimen
identification is clearly written on both the DBS card and on the plastic bag.
Ensure the humidity indicator can be read without opening the bag. Gently apply
pressure to the partially sealed bag to expel the air before sealing it completely.
Place 5-10 of the above small bags into a large plastic bag.
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which For shipments that are in transit for up to 14 days, maintain at ambient
Include Specimen Handling temperature (20-30C) and for greater than 14 days, maintain temperature
Requirements at -20C or colder with dry ice.
Methodology Identification of mutations within HIV-1 pol gene region, Sequencing
Turnaround Time 24 Weeks
Interferences & Limitations Do not use heparin as an anticoagulant. Plasma and serum should not be used

Tuesday, November 29, 2016 Version: 1.1 Page 161 of 363


Test Order
HIV- Genotype Drug Resistance (International Only)
CDC-10335

after more than 2 freeze-thaw cycles. Plasma or serum will be rejected if


improperly labeled or unlabeled, or with discrepant documentation, insufficient
volume, without documentation, unacceptable preservatives, and specimen that
have leaked in transit or otherwise shown evidence of contamination.

Dried blood spots will be rejected if improperly labeled or unlabeled, without


documentation or with discrepant documentation, without humidity indicators
and desiccants, demonstrating any indication of humidity in the zip lock bags,
insufficient volume for testing, improperly collected, containing blood clots or
clumps, with a halo around the blood spot indicating contamination, if specimen
are congruent or show evidence of commingling and collected onto
inappropriate filter paper.
Additional lnformation The In-house assay may not detect minor viral species that constitute less than
20% of the circulating virus population. Consultation with an expert in HIV drug
resistance is encouraged to facilitate interpretation of genotype test results, and
to evaluate which mutations and/or combinations of mutations are associated
with drug resistance.
CDC Points of Contact Chunfu Yang (Primary POC)
(404) 639-4975
cxy0@cdc.gov
Joshua DeVos (Secondary POC)
(404) 639-5442
ext8@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 162 of 363


Test Order
HIV- Nucleic Acid Amplification (Qualitative)
CDC-10275

Synonym(s) HIV NAAT


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, plasma or whole blood. Specimens may be collected EDTA, ACD sodium
Type for Testing citrate, PPT, or serum tubes. Follow sample tube manufacturer's instructions
Minimum Volume Required 1 mL

Storage & Preservation of Specimen stability is affected by elevated temperature. Whole blood, plasma or
Specimen Prior to Shipping serum may be stored for up to 72 hours from time of draw at <= 25C;
temperatures not to exceed 30C are acceptable for no more than 24 hours.
Specimens may be stored an additional five days at 2 to 8C following
centrifugation. Plasma separated from the cells may be stored for longer periods
of time at <= 20C before testing. Do not freeze whole blood. Long-term
storage of serum has not been evaluated.
Transport Medium Not Applicable
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Keep specimen at room temperature. If frozen, specimen should be shipped on
dry ice.
Methodology Nucleic acid amplification
Turnaround Time 21 Days
Interferences & Limitations Collections in heparin coated tubes are unacceptable due to heparin interference
with nucleic acid amplification
Additional lnformation For RNA testing, separate the plasma by centrifugation and freeze (-70C is
optimal, -20C acceptable) as soon as possible after separation (min volume of
1mL of plasma is required, 5 mLs is optimal). For DNA amplification, (required
for HIV-2), freeze the cell pellet after plasma separation (-70C is optimal, -20C
acceptable). Indicate the original volume of blood used to generate the pellet on
the shipping form. If blood separation is not possible, tubes may be shipped
overnight at ambient temperature.
CDC Points of Contact Bill Switzer
(404) 639-0219
bis3@cdc.gov
Tim Granade
(404) 639-3850
txg1@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 163 of 363


Test Order
HIV- Nucleic Acid Amplification (Viral Load)
CDC-10276

Synonym(s) HIV RNA-PCR, HIV RT-PCR, HIV Roche Viral load, HIV Cobas, HIV Abbot Viral
load, HIV NAAT
Pre-Approval Needed Granade, Tim, (404) 639-3850, txg1@cdc.gov
Switzer, Bill, (404) 639-0219, bis3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Plasma collected in EDTA anticoagulant.


Type for Testing
Follow manufacturer's instructions for proper collection.
Minimum Volume Required 1 mL

Storage & Preservation of Fresh whole blood may be held at 15-30C for up to 6 hours or at 2-8C for up
Specimen Prior to Shipping to 24 hours. After centrifugation, plasma may be stored at 15-30C for up to 24
hours and at 2-8C for up to 5 days. Plasma may be frozen at -20C for up to 6
weeks (42 days); longer storage should be at -70C or colder. Freeze-thaw
cycles should be avoided and should not exceed 3 cycles
Transport Medium Not Applicable
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Keep specimen at room temperature. If frozen, specimen should be shipped on
dry ice.
Methodology Real time polymerase chain reaction (RT-PCR)
Turnaround Time 21 Days
Interferences & Limitations Collections in heparin coated tubes are unacceptable due to heparin interference
with PCR amplification.
Additional lnformation For RNA testing, separate the plasma by centrifugation and freeze (-70C is
optimal, -20C acceptable) as soon as possible after separation (min volume of
1mL of plasma is required, 5 mL is optimal).
CDC Points of Contact Tim Granade
(404) 639-3850
txg1@cdc.gov
Bill Switzer
(404) 639-0219
bis3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 164 of 363


Test Order
HIV- PCR (International Only) Qualitative
CDC-10336

Synonym(s) HIV, EID, PMTCT, Early infant diagnostic, DNA


Pre-Approval Needed Hurlston, MacKenzie, (404) 639-1281, wpd9@cdc.gov
Diallo, Karidia, (404) 639-3568, edu9@cdc.gov
Supplemental Information Specimens must be accompanied with complete requisition form(s)
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Dried Blood Spots (DBS). At least 4 saturated 13mm circles (preferably 5)
Type for Testing containing 50-100 L of whole blood including capillary blood obtained by
finger/toe/heel stick which is dropped directly onto the DBS card.
Minimum Volume Required Not Applicable

Storage & Preservation of The appropriate anticoagulant for DBS whole blood collection is EDTA.
Specimen Prior to Shipping
Dried blood spots should be kept at an ambient temperature (15-35C) for
testing performed within 14 days and frozen at -70C if testing is not performed
within 14 days.
Transport Medium Transport specimen in a gas impermeable plastic bag with desiccant and
humidity indicator card. Each DBS card needs to be packaged separately.
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which For shipments that are in transit for up to 14 days, maintain at ambient
Include Specimen Handling temperature (15-35C) and shipments that are in transit for greater than 14
Requirements days, maintain temperature at -20C or colder with dry ice.
Methodology Qualitative PCR
Turnaround Time 28 Days
Interferences & Limitations Do not use heparin as an anticoagulant. Specimen will be rejected if improperly
labeled or unlabeled, without documentation or with discrepant documentation,
without humidity indicators and desiccants, demonstrating any indication of
humidity in the zip lock bags, insufficient volume for testing, improperly
collected, containing blood clots or clumps, with a halo around the blood spot
indicating contamination, if specimen are congruent or show evidence of
commingling and collected onto inappropriate filter paper.
Additional lnformation A test result of "HIV-1 Not Detected" or Target not detected, does not rule out
necessarily HIV-1 DNA for the Amplicor test or HIV-1 RNA and DNA for the
COBAS AmpliPrep platform. Either nucleic acid (HIV-1 DNA/RNA) concentrations
below the limit of detection of the assays, the presence of PCR inhibitors in the
patient specimen or improper specimen handling can lead to false negative
results. PCR may not detect infection in the first weeks of infants life (< 6
weeks) or within 6 weeks of weaning. HIV-1 may not be detected immediately
after exposure. The diagnosis of HIV-1 infection is based on clinical presentation
and results from additional diagnostic tests such as DNA PCR. Diagnosis should

Tuesday, November 29, 2016 Version: 1.4 Page 165 of 363


Test Order
HIV- PCR (International Only) Qualitative
CDC-10336

not be based solely on a single HIV-1 test. False positive test results may be
caused by PCR contamination.
NOTE: If a specific testing platform is required, requests must be submitted and
reviewed by the team lead.
CDC Points of Contact MacKenzie Hurlston (Primary POC)
(404) 639-1281
wpd9@cdc.gov
Karidia Diallo (Secondary POC)
(404) 639-3568
edu9@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 166 of 363


Test Order
HIV- PCR (International Only) Quantitative Viral Load
CDC-10337

Synonym(s) HIV, VL, RNA


Pre-Approval Needed Hurlston, MacKenzie, (404) 639-1281, wpd9@cdc.gov
Diallo, Karidia, (404) 639-3568, edu9@cdc.gov
Supplemental Information Specimens must be accompanied with complete requisition form(s).
Required
CDC Form 0.753: Application for Permit to Import or
Transport Etiological Agents, Hosts, or Vectors of Human Disease and
Requisition Form
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Plasma


Type for Testing
Minimum Volume Required 0.2 mL

Storage & Preservation of The appropriate anticoagulant for whole blood collection is EDTA.
Specimen Prior to Shipping
Specimen should be kept at ambient temperature (20-35C) within 14 days after
collection, but frozen at -70C if testing is to be performed after 14 days.
Transport Medium Transport specimen in a sterile 1.5-2.0 mL polypropylene tube, screw cap with
O-ring
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which For shipments that are in transit for up to 5 days, maintain at (2-8C) and
Include Specimen Handling shipments in transit for greater than 5 days, maintain temperature at -20C or
Requirements colder with dry ice.
Methodology Quantitative PCR
Turnaround Time 28 Days
Interferences & Limitations Do not use heparin as an anticoagulant. Do not use specimens after more than 5
freeze-thaw cycles for the Roche assays and 3 freeze-thaw cycles for the Abbott
m2000 assay. Specimen will be rejected if improperly labeled or unlabeled, or
with discrepant documentation, insufficient volume, without documentation,
unacceptable preservatives, and specimen that have leaked in transit or
otherwise shown evidence of contamination.
Additional lnformation An interpretation of Target Not Detected, HIV-1 RNA Not Detected , and Not
Detected" does not rule out the presence of PCR inhibitors or HIV-1 RNA
concentrations below the level of detection of the assay. Care should be taken in
the interpretation of any single viral load determination. The clinical significance
of changes in HIV-1 RNA measurements has not been fully established; however,
a change of 0.5 log copies/mL may be significant.
The linear range of each assay is as follows:
COBAS AmpliPrep/COBAS Taqman v2.0 is 20-10,000,000
copies/mL(1.30log-7.00log)

Tuesday, November 29, 2016 Version: 1.3 Page 167 of 363


Test Order
HIV- PCR (International Only) Quantitative Viral Load
CDC-10337

Amplicor HIV-1 Monitor v1.5 is 400-750,000 copies/mL(2.60log-5.88log)


Abbott Real Time HIV-1 assay is 40-10,000,000 copies/mL(1.60-7.00log)
The COBASAmpliPrep/COBAS Taqman HIV-1 v2.0 test exhibits a higher level
of sensitivity when compared to the Amplicor HIV-1 Monitor v1.5 test and the
Abbott Real Time HIV-1 test for the m2000 system.
NOTE: If a specific testing platform is required, requests must be submitted and
reviewed by the Team Lead.
CDC Points of Contact MacKenzie Hurlston (Primary POC)
(404) 639-1281
wpd9@cdc.gov
Karidia Diallo (Secondary POC)
(404) 639-3568
edu9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 168 of 363


Test Order
HIV- / Antibody (International Only) EIA and Western Blot
CDC-10338

Synonym(s) HIV, EIA, WB, ELISA


Pre-Approval Needed Parekh, Bharat, (404) 639-3647, bsp1@cdc.gov
Kalou, Mireille, (404) 639-2794, chn7@cdc.gov
Supplemental Information Specimens must be accompanied with complete requisition form(s).
Required
Plasma or serum:
CDC Form 0.753: Application for Permit to Import or
Transport Etiological Agents, Hosts, or Vectors of Human Disease and
Requisition Form

Dried Blood Spots:


Requisition Form
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Plasma, serum and dried blood spots. Dried Blood Spots should be at least 4
Type for Testing saturated 13mm filter paper circles (preferably 5) containing 75 L of whole
blood.
Minimum Volume Required 0.5 mL (plasma and serum)

Storage & Preservation of Keep plasma and serum refrigerated at 2-8C if testing is performed within 7
Specimen Prior to Shipping days. If testing is performed after 7 days of collection, the specimen should be
kept frozen at -20C or colder.

Dried blood spots should be stored at an ambient temperature (20-30C) if


testing is performed within 14 days. Specimen should be frozen at -20C or
colder if testing is not performed within 14 days.

Plasma: The appropriate anticoagulants for whole blood collection are either
EDTA, Sodium heparin or Lithium heparin.

Dried Blood Spots: For DBS prepared from whole blood collected into tubes, the
appropriate anticoagulant for DBS whole blood collection is EDTA. Finger pricks
without anti-coagulant dropped directly onto filter paper is also acceptable.
Transport Medium Transport plasma and/or serum in plastic screw-cap vial with O-ring. Dried
blood spots should be in gas impermeable plastic bag with desiccant and
humidity indicator card and packaged separately.
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which For shipments that are in transit for up to 7 days, maintain temperature at 2-8C.
Include Specimen Handling For shipments that are in transit for greater than 7 days, maintain temperature
Requirements at -20C or colder with dry ice.

For shipments that are in transit for up to 14 days, maintain at ambient


temperature (20-30C). For shipments that are in transit for greater than 14
Tuesday, November 29, 2016 Version: 1.1 Page 169 of 363
Test Order
HIV- / Antibody (International Only) EIA and Western Blot
CDC-10338

days, maintain temperature at -20C or colder with dry ice.


Methodology Enzyme Immunoassay, Enzyme-linked Immunosorbent Blot Technique (Western
Blot)
Turnaround Time 90 Days
Interferences & Limitations Do not use plasma and serum after more than 5 freeze-thaw cycles. Plasma or
serum will be rejected if improperly labeled or unlabeled, without documentation
or with discrepant documentation, insufficient volume, unacceptable
preservatives, and specimen that have leaked in transit or otherwise shown
evidence of contamination.

Dried blood spots will be rejected if improperly labeled or unlabeled, without


documentation or with discrepant documentation, without humidity indicators
and desiccants, demonstrating any indication of humidity in the zip lock bags,
insufficient volume for testing, improperly collected, containing blood clots or
clumps, with a halo around the blood spot indicating contamination, if specimen
are congruent or show evidence of commingling and collected onto
inappropriate filter paper.
Additional lnformation Positive results are confirmed by the highly specific method (i.e. Western Blot).
Western Blot with an EIA-positivity has combined specificity of greater than
99.9%.

Testing for EIA and Western Blot is perfumed in batches and the turnaround
times are the following:

Batch with less than 200 specimens within 50 days


Batch with 200-600 within 70 days
Batch with greater than 600 specimens within 90 days
CDC Points of Contact Bharat Parekh
(404) 639-3647
bsp1@cdc.gov
Mireille Kalou
(404) 639-2794
chn7@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 170 of 363


Test Order
HIV- / Antibody (International Only) Rapid Test
CDC-10339

Synonym(s) HIV, RT
Pre-Approval Needed Parekh, Bharat, (404) 639-3647, bsp1@cdc.gov
Kalou, Mireille, (404) 639-2794, chn7@cdc.gov
Supplemental Information Specimens must be accompanied with complete requisition form(s).
Required
CDC Form 0.753: Application for Permit to Import or
Transport Etiological Agents, Hosts, or Vectors of Human Disease and
Requisition Form
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Plasma and serum


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of The appropriate anticoagulants for whole blood collection are EDTA or Sodium
Specimen Prior to Shipping heparin. Keep specimen at ambient temperature at 15-35C if testing will be
performed within 48 hours of collection. If testing is to be performed within 7
days keep specimen refrigerated at 2-8C. If testing is to be performed after 7
days, keep specimen frozen at -20C or colder.
Transport Medium Specimen should be transported in a plastic screw-cap vial
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which For shipments that are in transit for up to 7 days, maintain temperature at 2-8C
Include Specimen Handling and for shipments that are in transit for greater than 7 days, maintain
Requirements temperature at -20C or colder with dry ice.
Methodology Immuno-concentration
Turnaround Time 90 Days
Interferences & Limitations Do not use specimens after more than 5 freeze-thaw cycles. Specimen will be
rejected if improperly labeled or unlabeled, without documentation or with
discrepant documentation, insufficient volume, unacceptable preservatives, and
specimen that have leaked in transit or otherwise shown evidence of
contamination.
Additional lnformation Turn around times are dependent on batch specimen:

Batch with less than 200 specimens within 50 days


Batch with 200-600 within 70 days
Batch with greater than 600 specimens within 90 days
CDC Points of Contact Bharat Parekh
(404) 639-3647
bsp1@cdc.gov
Mireille Kalou
(404) 639-2794
Tuesday, November 29, 2016 Version: 1.1 Page 171 of 363
Test Order
HIV- / Antibody (International Only) Rapid Test
CDC-10339

chn7@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 172 of 363


Test Order
HIV- / Laboratory Algorithm
CDC-10272

Synonym(s) HIV ELISA, HIV antibody


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and/or plasma. The following anticoagulants are acceptable: EDTA,
Type for Testing sodium citrate, CPD, CPDA-1, and ACD. SST and PPT are also acceptable.
Minimum Volume Required 1 mL

Storage & Preservation of Specimens may be stored at 2-8C for 7 days. Long-term storage should be
Specimen Prior to Shipping at -20C or colder and specimens should not have incurred more than 5 freeze-
thaw cycles.
Transport Medium Not Applicable
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology HIV antigen/antibody combo ELISA or HIV antibody ELISA, HIV-1/2
differentiation assay, Rapid Test, HIV-1 Nucleic acid amplification (qualitative)
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Tim Granade
(404) 639-3850
txg1@cdc.gov
Bill Switzer
(404) 639-0219
bis3@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 173 of 363


Test Order
HIV- Nucleic Acid Amplification (Qualitative)
CDC-10429

Synonym(s) HIV NAAT


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and plasma


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen should be properly stored in ethylenediaminetetraacetic acid (EDTA) or
Specimen Prior to Shipping Acid Citrate Dextrose (ACD) tubes. Serum and plasma can be stored at room
temperature. For plasma only collections, Plasma Preparation Tubes (PPT) are
suitable.
Transport Medium Not Applicable
Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Keep specimen at room temperature. If frozen, specimen should be shipped on
dry ice.
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 21 Days
Interferences & Limitations Collections in heparin coated tubes are unacceptable due to heparin interference
with PCR amplification.
Additional lnformation For RNA testing, separate the plasma by centrifugation and freeze (-70C is
optimal, -20C acceptable) as soon as possible after separation (min volume of
1mL of plasma is required, 5 mL is optimal). For DNA amplification, (required for
HIV-2), freeze the cell pellet after plasma separation (-70C is optimal, -20C
acceptable). Indicate the original volume of blood used to generate the pellet on
the shipping form. If blood separation is not possible, tubes may be shipped
overnight at ambient temperature.
CDC Points of Contact Bill Switzer
(404) 639-0219
bis3@cdc.gov
Tim Granade
(404) 639-3850
txg1@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 174 of 363


Test Order
HIV- Serology
CDC-10273

Synonym(s) HIV ELISA, HIV antibody


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and/or plasma. The following anticoagulants are acceptable: EDTA,
Type for Testing sodium citrate, CPD, CPDA-1, and ACD. SST and PPT are also acceptable.
Minimum Volume Required 1.0 mL

Storage & Preservation of Keep specimen either refrigerated or frozen. Plasma should be properly stored in
Specimen Prior to Shipping ethylenediaminetetraacetic acid (EDTA) or Acid Citrate Dextrose (ACD) tubes.

Transport Medium Not Applicable


Specimen Labeling Specimens and accompanying submission forms require 2 unique patient
identifiers. Identifiers that protect the identity of the individual are preferred
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology HIV-1/2 Differentiation Assay, HIV-2 Western Blot
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Tim Granade
(404) 639-3850
txg1@cdc.gov
Bill Switzer
(404) 639-0219
bis3@cdc.gov

Tuesday, November 29, 2016 Version: 2.2 Page 175 of 363


Test Order
HPV Special Study
CDC-10131

Synonym(s) None
Pre-Approval Needed Unger, Elizabeth, (404) 639-3533, eru0@cdc.gov
Panicker, Gitika, (404) 639-2269, dhv1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Polymerase Chain Reaction (PCR), Serology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation
CDC Points of Contact Elizabeth Unger Troy Querec
(404) 639-3533 (404)639-2864
eru0@cdc.gov hep0@cdc.gov
Gitika Panicker
(404) 639-2269
dhv1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 176 of 363


Test Order
Human Herpes Virus (HHV ) Detection and Subtyping
CDC-10266

Synonym(s) HHV6
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Saliva, cerebrospinal fluid (CSF) or blood


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes.

Transport Medium None


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 177 of 363


Test Order
Human Herpes Virus (HHV ) Serology
CDC-10497

Synonym(s) None
Pre-Approval Needed Schmid, Scott, (404) 639-0066, SSchmid@cdc.gov
Folster, Jennifer, (404) 639-3668, JFolster@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or plasma


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Fresh serum or plasma samples may be stored at 4 degrees C for up to one
Specimen Prior to Shipping week. Serum or plasma separated from red blood cells should be stored frozen
(-20 degrees C) until ready for testing.
Transport Medium No transport medium.
Specimen Labeling Clearly identify the sample and an associated patient ID number.
Shipping Instructions which If stored at 4 degrees C can be overnighted on cold packs in well-sealed O-ring
Include Specimen Handling vials; if frozen can be overnighted on dry ice in well-sealed O-ring vials.
Requirements
Methodology ELISA
Turnaround Time 7 Days
Interferences & Limitations False positive results may be obtained if samples are excessively lipemic or
contaminated by bacteria. False negative results may be obtained if samples are
not properly stored after collection.
Additional lnformation HHV-6 antibody detection method (HHV-6 ELISA) used to detect HHV-6 IgG
specific antibodies in human serum or plasma.
This protocol is not operated currently under the CLIA certificate, as it is still in
the process of being evaluated and validated; it is for research purposes only.
CDC Points of Contact Scott Schmid
(404) 639-0066
SSchmid@cdc.gov
Jennifer Folster
(404) 639-3668
JFolster@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 178 of 363


Test Order
Human Herpes Virus (HHV ) Detection
CDC-10267

Synonym(s) HHV7
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Saliva, cerebrospinal fluid (CSF) or blood


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes.

Transport Medium Not applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 179 of 363


Test Order
Human Herpes Virus (HHV ) Detection
CDC-10268

Synonym(s) Kaposi's sarcoma-associated herpesvirus, KSHV, HHV8


Pre-Approval Needed Dollard, Sheila, (404) 639-2178, sgd5@cdc.gov
Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood or saliva


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen. Blood should be collected in EDTA
Specimen Prior to Shipping or citrate tubes.

Transport Medium Not Applicable


Specimen Labeling Provide a specimen ID. Do not send specimen labeled with patients name.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Sheila Dollard
(404) 639-2178
sgd5@cdc.gov
Scott Schmid
(404) 639-0066
dss1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 180 of 363


Test Order
Human Herpes Virus (HHV ) Serology
CDC-10269

Synonym(s) Kaposi's sarcoma-associated herpesvirus, KSHV, HHV8


Pre-Approval Needed Dollard, Sheila, (404) 639-2178, sgd5@cdc.gov
Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or plasma


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen.


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Provide a specimen ID. Do not send specimen labeled with patients name.
Shipping Instructions which Ship overnight MondayThursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology IgG antibody detected by IFA
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Sheila Dollard
(404) 639-2178
sgd5@cdc.gov
Scott Schmid
(404) 639-0066
dss1@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 181 of 363


Test Order
Influenza Antiviral Resistance Diagnosis
CDC-10423

Synonym(s) Flu, Influenza Drug resistance, Neuraminidase inhibitor, Influenza Resistance


testing
Pre-Approval Needed None
Supplemental Information Requires additional WHO submission form that can be obtained with your
Required password
Supplemental Form http://www.nltn.org/Influenza-Specimen-submission-Form.xlsx
Performed on Specimens From Human

Acceptable Sample/ Specimen Must type/subtype prior to submission. Virus isolates, RNA, respiratory clinical
Type for Testing specimens (nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates,
nasal washes, lower respiratory tract specimens), and others upon consultation
with the laboratory.
Minimum Volume Required 0.5 mL

Storage & Preservation of Swab specimens should be collected using only swabs with a synthetic tip, such
Specimen Prior to Shipping as nylon or Dacron, and an aluminum or plastic shaft. Ensure that, when
transporting human respiratory specimens, all applicable regulations
for the transport of etiologic agents are met. Specimens received cold should be
stored refrigerated (28C) for up to 72 hours before processing. Store any
residual specimens at -70C. Although optimal performance is met when
testing fresh specimens within 72 hours of collection, performance has been
demonstrated with frozen specimens. If testing of a fresh specimen is not
possible within 72 hours storage at 28C, the specimen may be frozen at
-70C and tested at a later time. Specimens received frozen should be stored
at -70C until processing. Store any residual specimens at -70C.
Transport Medium Swabs must be in viral transport medium
Specimen Labeling Specimen ID must match the ID on the form
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Prior to shipping,
Include Specimen Handling notify CDC Influenza Division that you are sending specimens. Refer to the
Requirements International Air Transport Association (IATA - www.iata.org) for requirements
for shipment of human or potentially infectious biological specimens. Ship
extracted RNA and frozen specimen on dry ice. Refrigerated specimens should
be shipped on cold packs.
Methodology Pyrosequencing
Turnaround Time 3 Days
Interferences & Limitations Low viral load (Ct values above 29 are not recommended for submission) or
genetic variance can affect test results.

Calcium alginate swabs are unacceptable and cotton swabs with wooden shafts
are not recommended because it can cause a false-negative result.
Additional lnformation Turn around time may be greater than 3 days during holidays. Testing is not
performed on the weekends or on federal holidays.
CDC Points of Contact Larisa Gubareva David Wentworth
(404) 639-3204 (404) 639-3387
LGubareva@cdc.gov DWentworth@cdc.gov
Michelle Adamczyk
(404) 639-2276
MAdamczyk@cdc.gov

Tuesday, November 29, 2016 Version: 1.5 Page 182 of 363


Test Order
Influenza Molecular Diagnosis
CDC-10421

Synonym(s) Influenza Real Time PCR, Influenza Diagnostics, Flu


Pre-Approval Needed None
Supplemental Information Requires additional WHO submission form that can be obtained with your
Required password
Supplemental Form http://www.nltn.org/Influenza-Specimen-submission-Form.xlsx

Performed on Specimens From Human

Acceptable Sample/ Specimen Virus isolates, RNA, respiratory clinical specimens (i.e. Nasopharyngeal swabs,
Type for Testing nasal swabs, throat swabs, nasal aspirates, nasal washes, lower respiratory tract
specimens), and others upon consultation with the laboratory.
Minimum Volume Required 1 mL

Storage & Preservation of Swab specimens should be collected using only swabs with a synthetic tip, such
Specimen Prior to Shipping as nylon or Dacron, and an aluminum or plastic shaft. Ensure that, when
transporting human respiratory specimens, all applicable regulations
for the transport of etiologic agents are met. Specimens received cold should be
stored refrigerated (28C) for up to 72 hours before processing. Store any
residual specimens at -70C. Although optimal performance is met when
testing fresh specimens within 72 hours of collection, performance has been
demonstrated with frozen specimens. If testing of a fresh specimen is not
possible within 72 hours storage at 28C, the specimen may be frozen at -70
C and tested at a later time. Specimens received frozen should be stored at
-70C until processing. Store any residual specimens at -70C.
Transport Medium Swabs must be in viral transport medium
Specimen Labeling Specimen ID must match the ID on the form
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Urgent specimen
Include Specimen Handling can be shipped any time with prior approval from the laboratory. Prior to
Requirements shipping, notify CDC Influenza Division that you are sending specimen. Refer to
the International Air Transport Association (IATA - www.iata.org) for
requirements for shipment of human or potentially infectious biological
specimens.

Ship extracted RNA and frozen specimen on dry ice.


Refrigerated specimen should be shipped on cold packs.
Methodology Real Time PCR, Genetic Sequence Identification
Turnaround Time 7 Days
Interferences & Limitations Low virus numbers or co-infections can affect test results. Calcium alginate
swabs are unacceptable and cotton swabs with wooden shafts are not
recommended because it can cause a false-negative result.
Additional lnformation Specimens requiring additional testing and specimens submitted for surveillance
studies will take longer than seven days for results.
CDC Points of Contact Stephen Lindstrom
(404) 639-1587
sql5@cdc.gov
LaShondra Berman
(404) 639-1686
zhj5@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 183 of 363


Test Order
Influenza Serology
CDC-10424

Synonym(s) Influenza Hemagglutination inhibition assay, Influenza microneutralization assay


Pre-Approval Needed Levine, Min, (404) 639-3504, mwl2@cdc.gov
Katz, Jackie, (404) 639-4966, jmk9@cdc.gov
Supplemental Information Supplemental form will be supplied upon consultation with laboratory
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired Serum; Acute (less than 7 days post symptoms onset) and convalescent (at
Type for Testing least 14 days after acute serum collection)
Minimum Volume Required .5 mL

Storage & Preservation of Should be collected and immediately frozen. Specifics around storage and
Specimen Prior to Shipping preservation are supplied on the supplemental form and upon consultation with
laboratory.
Transport Medium Not Applicable
Specimen Labeling Please include patient identification number, patients age, date of collection and
symptoms onset date. Do not include names.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling Frozen specimen should be shipped on dry ice
Requirements
Obtain approval prior to shipping
Methodology Hemagglutination inhibition assay, Microneutralization assay
Turnaround Time 6 Weeks
Interferences & Limitations Whole blood cannot be used for testing. Lipemic or hemolyzed sera will affect
test results.
Additional lnformation None
CDC Points of Contact Min Levine Heather Tatum
(404) 639-3504
mwl2@cdc.gov gpg7@cdc.gov
Jackie Katz
(404) 639-4966
jmk9@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 184 of 363


Test Order
Influenza Special Study
CDC-10425

Synonym(s) None
Pre-Approval Needed Wentworth, David, (404) 639-3387, gll9@cdc.gov
Lindstrom, Stephen, (404) 639-1587, sql5@cdc.gov
Supplemental Information Requires additional WHO submission form that can be obtained with your
Required password
Supplemental Form http://www.nltn.org/Influenza-Speicmen-submission-Form.xls
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact David Wentworth Xu Xiyan
(404) 639-3387 (404) 639-1657
gll9@cdc.gov xxx1@cdc.gov
Stephen Lindstrom Larisa Gubareva
(404) 639-1587 (404) 639-3204
sql5@cdc.gov lqg3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 185 of 363


Test Order
Influenza Surveillance
CDC-10422

Synonym(s) Flu, Influenza Antigen Characterization


Pre-Approval Needed None
Supplemental Information Requires additional WHO submission form that can be obtained with your
Required password
Supplemental Form http://www.nltn.org/Influenza-Speicmen-submission-Form.xls
Performed on Specimens From Human

Acceptable Sample/ Specimen Respiratory specimens (nasopharyngeal swabs, nasal swabs, throat swabs, nasal
Type for Testing aspirates, nasal washes, dual nasopharyngeal/throat swabs, bronchoalveolar
lavage, sputum, tracheal aspirate, etc.), virus cultures, and others upon
consultation with the laboratory.
Minimum Volume Required 1 mL

Storage & Preservation of Swab specimens should be collected using only swabs with a synthetic tip, such
Specimen Prior to Shipping as nylon or Dacron, and an aluminum or plastic shaft. Ensure that, when
transporting human respiratory specimens, all applicable regulations
for the transport of etiologic agents are met. Specimens received cold should be
stored refrigerated (28C) for up to 72 hours before processing. Store any
residual specimens at -70C. Although optimal performance is met when
testing fresh specimens within 72 hours of collection, performance has been
demonstrated with frozen specimens. If testing of a fresh specimen is not
possible within 72 hours storage at 28C, the specimen may be frozen at
-70C and tested at a later time. Specimens received frozen should be stored
at -70C until processing. Store any residual specimens at -70C.
Transport Medium Swabs must be in viral transport medium
Specimen Labeling Specimen ID must match the ID on the form
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Urgent specimen
Include Specimen Handling can be shipped at any time with prior approval from the laboratory. Refer to the
Requirements International Air Transport Association (IATA - www.iata.org) for requirements
for shipment of human or potentially infectious biological specimens.

Ship extracted RNA and frozen specimen on dry ice.


Refrigerated specimen should be shipped on cold packs.
Methodology Hemagglutination Inhibition (HI) test, Virus Culture
Turnaround Time 4 Weeks
Interferences & Limitations Low virus numbers or co-infections can affect test results. Calcium alginate
swabs are unacceptable and cotton swabs with wooden shafts are not
recommended because it can cause a false-negative result.
Additional lnformation Turn around time may take up to a month if the virus needs to be cultured. Turn
around time for isolates may be less than 1 month.
CDC Points of Contact Xiyan Xu
(404) 639-1657
xxx1@cdc.gov
Wendy Sessions
(404) 639-3211
gra6@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 186 of 363


Test Order
Junin Serology
CDC-10340

Synonym(s) Argentine Hemorrhagic Fever, AHF, arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 187 of 363


Test Order
Kyasanur Forest Disease Serology
CDC-10341

Synonym(s) KFD
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 188 of 363


Test Order
Laguna Negra Serology
CDC-10342

Synonym(s) HPS, hanta


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 189 of 363


Test Order
Lassa Fever Identification
CDC-10343

Synonym(s) Arenavirus
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 190 of 363


Test Order
Lassa Fever Serology
CDC-10344

Synonym(s) Arenavirus
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 191 of 363


Test Order
Legionella Special Study
CDC-10161

Synonym(s) None
Pre-Approval Needed , legionellalab@cdc.gov, ,
Raphael, Brian, (404) 639-4292, elx9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which Do not ship on Fridays or the day before a federal holiday. Please see attached
Include Specimen Handling shipping instructions for details.
Requirements http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact legionellalab@cdc.gov (Primary Contact) Jonas Winchell (Emergency)
(404)639-4921
jwinchell@cdc.gov
Brian Raphael (Emergency)
(404) 639-4292
elx9@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 192 of 363


Test Order
Legionella species Detection and Identification
CDC-10159

Synonym(s) Legionnaires' disease or LD, Legionellosis, Pontiac fever


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Human Origin: Isolates or primary specimens for culture. Acceptable clinical
Type for Testing specimens are sputum, bronchoalveolar lavage (BAL), lung tissue, endotracheal
tube (ETT), tracheal aspirate, and urine
Environmental Origin: Isolates only
Minimum Volume Required Contingent on specimen type. Please see attached shipping instructions for
details. http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Storage & Preservation of Clinical specimens should be frozen immediately. Isolates should be prepared on
Specimen Prior to Shipping appropriate slants [Buffered Charcoal Yeast (BCYE)] and shipped at 4C. Please
see attached shipping instructions for details.
http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Transport Medium BCYE or equivalent slants for isolates
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Do not ship on Fridays or the day before a federal holiday. Please see attached
Include Specimen Handling shipping instructions for details.
Requirements http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Methodology Culture, Serogrouping, Sequencing, Real Time PCR
Turnaround Time 4 Weeks
Interferences & Limitations Specimen should be acquired prior to antibiotic treatment. Improper specimen
storage and handling may result in inconclusive or inaccurate results.
Additional lnformation If only PCR is needed then turn around time will be shorter than 4 weeks
CDC Points of Contact legionellalab@cdc.gov (Primary Contact) Jonas Winchell (Emergency)
(404)639-4921
jwinchell@cdc.gov
Brian Raphael (Emergency)
(404) 639-4292
elx9@cdc.govv

Tuesday, November 29, 2016 Version: 2.0 Page 193 of 363


Test Order
Legionella species Molecular Subtyping
CDC-10160

Synonym(s) LD, Legionnaires' disease, Legionellosis, Pontiac fever


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Human Origin: Isolates, purified nucleic acid, or primary specimens. Acceptable
Type for Testing clinical specimens are sputum, bronchoalveolar lavage (BAL), lung tissue,
endotracheal tube (ETT), and tracheal aspirate.
Environmental Origin: Isolates only
Minimum Volume Required Contingent on specimen type. Please see attached shipping instructions for
details.
http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Storage & Preservation of Clinical specimens should be frozen immediately. Isolates should be prepared on
Specimen Prior to Shipping appropriate slants [Buffered Charcoal Yeast (BCYE)] and shipped at 4C. Please
see attached shipping instructions for details.
http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Transport Medium BCYE or equivalent slants for isolates
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Do not ship on Fridays or the day before a federal holiday. Please see attached
Include Specimen Handling shipping instructions for details.
Requirements http://www.cdc.gov/legionella/downloads/shipping-instructions.pdf
Methodology Real Time PCR, Sequencing
Turnaround Time 4 Weeks
Interferences & Limitations Specimen should be acquired prior to antibiotic treatment. Improper specimen
storage and handling may result in inconclusive or inaccurate results.
Additional lnformation None
CDC Points of Contact legionellalab@cdc.gov (Primary Contact) Jonas Winchell (Emergency)
(404)639-4921
jwinchell@cdc.gov
Brian Raphael (Emergency)
(404) 639-4292
elx9@cdc.gov

Tuesday, November 29, 2016 Version: 3.0 Page 194 of 363


Test Order
Leishmania species Identification
CDC-10238

Synonym(s) Parasite
Pre-Approval Needed None
Supplemental Information Must contact CDC prior to sample collection at bnz0@cdc.gov, and CDC will
Required provide the culture medium (typically Novy-MacNeal-Nicolle (NNN) medium).
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Tissue, blood, bone marrow


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Culture medium (typically Novy-MacNeal-Nicolle (NNN) medium). Keep media
refrigerated until it is used (stable for 2-4 weeks) and bring it to room
temperature right before inoculation. Once inoculated, keep the culture at room
temperature and send to CDC as soon as possible by overnight mail.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Culture should
Include Specimen Handling be kept at room temperature and mailed as soon as possible, as an etiologic
Requirements agent. Blood and bone marrow should be shipped on wet ice (cold pack).
Methodology PCR and DNA sequencing, Culture
Turnaround Time 6 Weeks
Interferences & Limitations Formalin fixed specimens are not suitable for culture
Additional lnformation None
CDC Points of Contact Marcos de Almeida
(404) 718-4175
bnz0@cdc.gov
Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov

Tuesday, November 29, 2016 Version: 3.0 Page 195 of 363


Test Order
Leishmaniasis Serology
CDC-10463

Synonym(s) Leishmaniasis Serology, Visceral leishmaniasis, Kala azar; Leishmania donovoni,


Leishmania major, Leishmania, parasite
Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Antibody detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Marcos de Almeida
(404) 718-4175
bnz0@cdc.gov
Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov

Tuesday, November 29, 2016 Version: 4.0 Page 196 of 363


Test Order
Leptospira species Identification and Genotyping
CDC-10199

Synonym(s) Leptospirosis
Pre-Approval Needed Galloway, Renee, (404) 639-5461, zul0@cdc.gov
Stoddard, Robyn, (40) 463-9205, frd8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Isolate and media inoculated with clinical specimens (blood, tissue and urine)
Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Cultures should be stored at room temperature


Specimen Prior to Shipping

Transport Medium Isolates need to be shipped on Ellinghausen-McCullough-Johnson-Harris (EMJH)


semisolid media
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Isolates should be shipped at room temperature. All other specimens shipped at
4C.
Methodology Multilocus sequence typing (MLST), Pulsed field gel electrophoresis (PFGE),
Microscopy, Polymerase Chain Reaction (PCR)
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation Turnaround time will vary depending on if an isolate is sent for identification or
a specimen is sent for isolation. Primary isolation from clinical specimens takes
up to 6 months.
CDC Points of Contact Renee Galloway
(404) 639-5461
zul0@cdc.gov
Robyn Stoddard
(404) 639-2053
frd8@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 197 of 363


Test Order
Leptospira species Molecular Detection
CDC-10200

Synonym(s) Leptospirosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Clinical specimens (blood, CSF, and urine). Blood specimens should be collected
Type for Testing in EDTA or Sodium Citrate tubes
Minimum Volume Required 250 uL

Storage & Preservation of Keep frozen at -20C


Specimen Prior to Shipping

Transport Medium Blood specimens transported in EDTA or Sodium Citrate tubes


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Specimens should be shipped frozen at -20C
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Weeks
Interferences & Limitations Blood specimens collected in heparin are not acceptable
Additional lnformation None
CDC Points of Contact Robyn Stoddard
(404) 639-2053
frd8@cdc.gov
Renee Galloway
(404) 639-5461
zul0@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 198 of 363


Test Order
Leptospira species Serology
CDC-10201

Synonym(s) Leptospirosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum (acute and convalescent preferred)


Type for Testing
Minimum Volume Required 100 uL

Storage & Preservation of Store serum at 4C before shipping


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Serum should be shipped at 4C
Methodology MAT-micro agglutination
Turnaround Time 2 Weeks
Interferences & Limitations
Additional lnformation
CDC Points of Contact Renee Galloway
(404) 639-5461
zul0@cdc.gov
Robyn Stoddard
(404) 639-2053
frd8@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 199 of 363


Test Order
Leptospira species Study
CDC-10202

Synonym(s) None
Pre-Approval Needed Galloway, Renee, (404) 639-5461, zul0@cdc.gov
Stoddard, Robyn, (404) 639-2053, frd8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Renee Galloway
(404) 639-5461
zul0@cdc.gov
Robyn Stoddard
(404) 639-2053
frd8@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 200 of 363


Test Order
Listeria Identification
CDC-10128

Synonym(s) Listeria
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens but is required for all other
Required specimen types.

Provide any preliminary results that are available.


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship growth on nonselective slant/stab such as TSA, HIA, etc.; screw cap tubes
preferred.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements Ship at ambient temperature in compliance with Federal and local guidelines

There are no time constraints for submitting sequence data


Methodology Phenotypic Identification, Genetic Identification
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Zuzana Kucerova
(404) 718-4143
zik0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 201 of 363


Test Order
Listeria monocytogenes Identification and Subtyping
CDC-10129

Synonym(s) Listeria Typing


Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens, but is required for all
Required other specimen types.

Provide any preliminary results available. Indicate subtyping method(s)


requested on specimen submission form.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, Sequence Data


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship growth on nonselective slant/stab such as TSA, HIA, etc.; screw cap tubes
preferred.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers for all
submissions, on the specimen container, and test requisition
Shipping Instructions which Ship isolates or cultures Monday-Thursday, overnight to avoid weekend
Include Specimen Handling deliveries.
Requirements
Ship at ambient temperature in compliance with Federal and local guidelines

There are no time constraints for submitting sequence data


Methodology Phenotypic Identification, Genetic Identification, PFGE
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities due to limited availability of resources.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Zuzana Kucerova
(404) 718-4143
zik0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 202 of 363


Test Order
Listeria Study
CDC-10130

Synonym(s) None
Pre-Approval Needed Tarr, Cheryl, (404) 639-2011, crt6@cdc.gov
Kucerova, Zuzana, (404) 718-4143, zik0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Zuzana Kucerova
(404) 718-4143
zik0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 203 of 363


Test Order
LRN Biothreat Multi-Agent Screening - Environmental
CDC-10430

Synonym(s) Screening for Bacillus anthracis,


Brucella spp., Burkholderia mallei, Burkholderia pseudomallei, Francisella
tularensis, Yersinia pestis, Orthopoxvirus, and ricin toxin.
Pre-Approval Needed Bowzard, Brad, (404) 639-3626, jbowzard@cdc.gov
Andersen, Lauren, (404) 639-4442, wrh5@cdc.gov
Supplemental Information Please contact Dr. Brad Bowzard at 404 639-3626 or jbowzard@cdc.gov, for
Required the required supplemental form and packaging and shipping requirements.
Supplemental Form None
Performed on Specimens From Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Bulk sampling of visible materials (e.g., powders, liquids, etc.) and/or sampling
Type for Testing from contaminated surfaces (e.g., with polyester swabs).
Minimum Volume Required Dependent on Specimen Type

Storage & Preservation of Dry swabs or powders can be stored and shipped at room temperature. Liquid
Specimen Prior to Shipping samples should be held and shipped at 4C.

Transport Medium None


Specimen Labeling No special requirements
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries, if possible. If
Include Specimen Handling weekend delivery is necessary, please contact laboratory upon shipment.
Requirements
Methodology Real Time PCR, Culture Isolation, Time-Resolved Fluorescence
Turnaround Time
Interferences & Limitations Dependent on sample time
Additional lnformation Turnaround time is dependent on test and sample type.
CDC Points of Contact Brad Bowzard
(404) 639-3626
jbowzard@cdc.gov
Lauren Andersen
(404) 639-4442
wrh5@cdc.gov

Tuesday, November 29, 2016 Version: 3.0 Page 204 of 363


Test Order
LRN Biothreat Multi-Agent Surface Samples - Environmental
CDC-10495

Synonym(s) Bacillus anthracis spore environmental swab and wipe processing procedures;
3M Sponge Stick, macrofoam swabs, surface samples
Pre-Approval Needed Bowzard, Brad, (404) 639-3626, jbowzard@cdc.gov
Andersen, Lauren, (404) 639-4442, wrh5@cdc.gov
Supplemental Information Please contact Dr. Brad Bowzard at 404 639-3626 or jbowzard@cdc.gov for the
Required required supplemental form and packaging and shipping requirements.
Supplemental Form None
Performed on Specimens From Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Sampling from surfaces with no visible contamination using Macrofoam swab or 3M
Type for Testing Sponge Stick; currently only applies for B. anthracis.
Minimum Volume Required For appropriate interpretation of results, defined sampling areas for each device
must be followed: Macrofoam swab = 26cm2 , 3M Sponge Stick = 645 cm2.
Storage & Preservation of Devices should be held at 4 degrees and shipped on ice within 24 hours of
Specimen Prior to Shipping collection.

Transport Medium None


Specimen Labeling No special requirements
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries, if possible. If
Include Specimen Handling weekend delivery is necessary, please contact laboratory upon shipment.
Requirements
Methodology Culture with RT-PCR confirmation of colonies
Turnaround Time 4 Days
Interferences & Limitations Large quantities of dust and/or other organisms may reduce limits of detection.
Additional lnformation Testing should be initiated within 24 hours of receipt. Turn around time ranges
from 1-4 days.
CDC Points of Contact Brad Bowzard
(404) 639-3626
jbowzard@cdc.gov
Lauren Andersen
(404) 639-4442
wrh5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 205 of 363


Test Order
Lymphocytic Choriomeningitis (LCM) Identification
CDC-10345

Synonym(s) LCM, Arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood, serum, and CSF


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 206 of 363


Test Order
Lymphocytic Choriomeningitis (LCM) Serology
CDC-10346

Synonym(s) LCM, Arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen CSF, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 207 of 363


Test Order
Machupo Identification
CDC-10347

Synonym(s) Bolivian Hemorrhagic Fever, BHF, Arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 208 of 363


Test Order
Machupo Serology
CDC-10348

Synonym(s) Bolivian Hemorrhagic Fever, BHF, Arenavirus


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 209 of 363


Test Order
Malaria Molecular Identification
CDC-10480

Synonym(s) Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, Plasmodium


ovale, parasite
Pre-Approval Needed None
Supplemental Information Please include the blood smear slides in the shipment
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood; Please include the blood smear slides in the shipment
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Collect a 1-5 ml blood sample in Vacutainer EDTA tubes prior to anti-parasitic
Specimen Prior to Shipping therapy and store at 4C.

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling on wet ice (cold pack) as an etiologic agent.
Requirements
Methodology Conventional PCR, Real-Time PCR
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Samaly dos Santos Souza
(404) 718-4786
ynp4@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 210 of 363


Test Order
Malaria Serology
CDC-10464

Synonym(s) Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, parasite


Pre-Approval Needed None
Supplemental Information Travel history REQUIRED, include other relevant risk factors; clinical symptoms,
Required treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Indirect Fluorescent Antibody Assay, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Hilda Rivera
(404) 718-4100
igi2@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 211 of 363


Test Order
Malaria Surveillance
CDC-10235

Synonym(s) Malaria Drug Resistance typing, parasite


Pre-Approval Needed None
Supplemental Information Supplemental form not needed
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Blood collected in EDTA tubes


Type for Testing
Minimum Volume Required 1.0 mL

Storage & Preservation of Blood should be collected in EDTA tubes


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Do not ship
Include Specimen Handling specimen frozen.
Requirements
Methodology Polymerase Chain Reaction (PCR), DNA Sequencing, In-vitro culture
Turnaround Time
Interferences & Limitations None
Additional lnformation Turnaround time is determined by the surveillance project, no individual patient
reports are issued

Please provide information on travel history and history of anti-malarial usage


CDC Points of Contact Venkatachalam Udhayakumar
(404) 718-4418
vxu0@cdc.gov
Naomi Lucchi
(404) 718-4406
nlucchi@cdc.gov

Tuesday, November 29, 2016 Version: 2.3 Page 212 of 363


Test Order
Marburg Identification
CDC-10349

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 213 of 363


Test Order
Marburg Serology
CDC-10350

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 214 of 363


Test Order
Measles and Rubella Detection (PCR) and Genotyping
CDC-10243

Synonym(s) Measles, Rubeola, Rubella, German measles; three day measles


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Throat swab in viral medium, Nasopharyngeal aspirate or swab, urine, cataracts,
Type for Testing lens aspirate, oral fluid, cerebrospinal fluid (CSF), dry blood spots, and tissue
samples
Minimum Volume Required Not Applicable

Storage & Preservation of Measles: http://www.cdc.gov/measles/lab-tools/


Specimen Prior to Shipping Rubella: http://www.cdc.gov/rubella/lab/index.html

Also see: http://www.cdc.gov/vaccines/pubs/surv-manual/index.html


http://www.cdc.gov/measles/lab-tools/index.html
Transport Medium Viral transport medium for swabs and appropriate culture medium. Make sure
tubes are all in leak proof containers.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which The laboratory requests that the sender contacts the laboratory by email or
Include Specimen Handling phone before shipping.
Requirements
For shipping address see: http://www.cdc.gov/measles/lab-tools/

Ship specimen Monday -Thursday overnight to avoid weekend deliveries

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on cold packs
Methodology Real time RT-PCR, Genotyping by nucleic acid sequencing, Template production
by RT-PCR, Viral culture
Turnaround Time 7 Days
Interferences & Limitations Measles: http://www.cdc.gov/measles/lab-tools/
Rubella: http://www.cdc.gov/rubella/lab/index.html

Also see, http://www.cdc.gov/vaccines/pubs/surv-manual/index.html


http://www.cdc.gov/measles/lab-tools/index.html
Additional lnformation Please include vaccination history, age, date of symptom onset and sample
collection
CDC Points of Contact Paul Rota
(404) 639-4181
par1@cdc.gov
Joe Icenogle
(404) 639-4557
jci1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 215 of 363


Test Order
Measles and Rubella Serology
CDC-10247

Synonym(s) Measles, Rubeola, Rubella, German measles, three day measles


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and others upon consultation with laboratory
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Serum should be kept refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Refrigerated or frozen specimen should be shipped on cold packs.
laboratory will instruct on how to ship for other specimen types.
Methodology Commercial capture IgM, Commercial indirect IgG
Turnaround Time 7 Days
Interferences & Limitations IgM positive may not occur until 5 days post-rash onset
Additional lnformation IgM and IgG assays are qualitative assays.
For outbreaks or immuno-compromised patients please contact laboratory prior
to shipment.
CDC Points of Contact Carole Hickman
(404) 639-3339
cjh3@cdc.gov
Joe Icenogle
(404) 639-4557
jci1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 216 of 363


Test Order
Measles Avidity
CDC-10248

Synonym(s) None
Pre-Approval Needed Mercader, Sara, (404) 639-4568, sjm7@cdc.gov
Hickman, Carole, (404) 639-3339, cjh3@cdc.gov
Supplemental Information See additional information
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 300 uL

Storage & Preservation of Serum should be kept refrigerated, not frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Provide a unique identifier on the specimen container and the test requisition
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Measles avidity
Turnaround Time 30 Days
Interferences & Limitations None
Additional lnformation http://www.cdc.gov/vaccines/pubs/surv-manual/index.html

The measles avidity assay is a specialized tool that may help with confirmation of
suspect cases with RT-PCR-negative results or with questionable IgM results
(false positive or false negative results are suspected). However, avidity results
cannot rule out cases. Avidity testing can also help in vaccine failure
classification. Assay limitations include difficulty in interpretation of results from
infants with potential presence of maternal antibodies or from individuals
recently immunized with measles vaccine.

Samples must be measles IgG positive for testing

The following information is required for result interpretation:


- Records of vaccination status, with the number of doses and dates of
administration
- Date of birth
- Date of rash onset
- Date of sample collection
- Clinical symptoms.

The MMRH Laboratory Branch reserves the right to determine if testing for
measles avidity could be beneficial.

CDC Points of Contact Sara Mercader


(404) 639-4568

Tuesday, November 29, 2016 Version: 1.3 Page 217 of 363


Test Order
Measles Avidity
CDC-10248

sjm7@cdc.gov
Carole Hickman
(404) 639-3339
cjh3@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 218 of 363


Test Order
Measles Detection (PCR) and Genotyping
CDC-10240

Synonym(s) Rubeola
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Throat swab in viral transport medium, nasopharyngeal aspirate or swab, urine,
Type for Testing oral fluid, cerebrospinal fluid (CSF), dry blood spots, and tissue samples
Minimum Volume Required Not Applicable

Storage & Preservation of See: http://www.cdc.gov/measles/lab-tools/rt-pcr.html for detailed information


Specimen Prior to Shipping on storage and preservation of specimen

Transport Medium Viral transport medium for swabs. Make sure tubes are all leak proof containers.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which The laboratory requests that the sender contacts the laboratory by email or
Include Specimen Handling phone before shipping
Requirements
See instructions and shipping address: http://www.cdc.gov/measles/lab-tools/

Ship specimen Monday -Thursday overnight to avoid weekend deliveries

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on cold packs
Methodology Viral culture, Genotyping by Nucleic acid sequencing, Real time RT-PCR,
Template production by RT-PCR
Turnaround Time 7 Days
Interferences & Limitations See: http://www.cdc.gov/measles/lab-tools/ for information on the
interferences and limitations of this test
Additional lnformation Please include vaccination history, age, date of rash onset and date of sample
collection

For additional information, please see measles surveillance manual:


http://www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.html
CDC Points of Contact Paul Rota
(404) 639-4181
par1@cdc.gov
Rebecca McNall
(404) 639-4541
dqo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 219 of 363


Test Order
Measles Neutralization Antibody (Not for Immune Status)
CDC-10250

Synonym(s) PRN test, Plaque-reduction neutralization


Pre-Approval Needed Hickman, Carole, (404) 639-3339, cjh3@cdc.gov
Sowers, Sun, (404) 639-1360, sib9@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/vaccines/pubs/surv-manual/index.html
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 300 uL

Storage & Preservation of Serum should be kept refrigerated, not frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Provide a unique identifier on the specimen container and the test requisition
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Neutralization assay - quantitative serological assay
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Carole Hickman
(404) 639-3339
cjh3@cdc.gov
Sun Sowers
(404) 639-1360
sib9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 220 of 363


Test Order
Measles Serology
CDC-10244

Synonym(s) Rubeola
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and others upon consultation


Type for Testing
Minimum Volume Required 300 uL (50 uL)

Storage & Preservation of Serum should be kept refrigerated, not frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Laboratory will instruct on how to ship for other specimen types
Methodology CDC capture IgM, Commercial indirect IgG
Turnaround Time 7 Days
Interferences & Limitations IgM positive may not occur until 4 days post-rash onset
Additional lnformation IgM and IgG assays are qualitative assays

For outbreaks or immuno-compromised patients please contact laboratory prior


to shipment

Please include vaccination history, age, date of onset and sample collection
CDC Points of Contact Carole Hickman
(404) 639-3339
cjh3@cdc.gov
Nobia Williams
(404) 639-1049
new8@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 221 of 363


Test Order
Measles Special Study
CDC-10251

Synonym(s) Rubeola
Pre-Approval Needed Rota, Paul, (404) 639-4181, par1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Paul Rota
(404) 639-4181
par1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 222 of 363


Test Order
MERS-CoV PCR
CDC-10488

Synonym(s) MERS-CoV PCR, Middle East Respiratory Syndrome Coronavirus PCR


Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/coronavirus/mers/downloads/MERS-investigation-short-
form.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal wash/aspirates, nasopharyngeal swabs, oropharyngeal swabs,


Type for Testing broncheoalveolar lavage, tracheal aspirate, pleural fluid tap, sputum, stool,
serum, EDTA blood (plasma), and post-mortem tissue. For more information go
to: http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html;
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate or freeze tubes after specimens are placed in them. If specimens will
Specimen Prior to Shipping be examined within 48 hours after collection, they can be refrigerated. If
specimens must be held longer than 48 hours, freeze them as soon as possible
after collection. Although storage in an ultra-low freezer (-70C) is preferable,
storage in a home-type freezer (if properly set at -20C) is acceptable for short
periods.

http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
Transport Medium Swabs may be shipped in commercial viral transport media
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Contact Dean Erdman (dde1@cdc.gov, 404-639-3727) for shipping address.
Include Specimen Handling
Requirements See the following link for additional shipping information:
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html
Methodology Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 2 Days
Interferences & Limitations Virus isolation in cell culture and initial characterization of viral agents
recovered in cultures of MERS-CoV specimens are NOT recommended at this
time. However, if done, these activities must be performed in a BSL-3 facility
using BSL-3 work practices.

Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays.
Additional lnformation http://www.cdc.gov/coronavirus/mers/index.html,
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html,
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili

Tuesday, November 29, 2016 Version: 1.2 Page 223 of 363


Test Order
MERS-CoV PCR
CDC-10488

(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 224 of 363


Test Order
MERS-CoV Serology
CDC-10489

Synonym(s) Middle East Respiratory Syndrome Coronavirus (MERS-CoV) ELISA, Middle East
Respiratory Syndrome Coronavirus (MERS-CoV) EIA
Pre-Approval Needed Tatti, Kathleen, (404) 639-3797, ket2@cdc.gov
Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/coronavirus/mers/downloads/MERS-investigation-short-
form.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum (single specimen collected >14 days after symptom onset; paired acute
Type for Testing and convalescent). For more information go to
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html
Minimum Volume Required 200L

Storage & Preservation of Collect whole blood in a serum separator tube. Allow the blood to clot,
Specimen Prior to Shipping centrifuge briefly, and collect all the resulting sera in vials with external caps and
internal O-ring seals. If there is no O-ring seal, then seal tightly with the
available cap and secure with Parafilm. Do not collect specimen in heparin tubes.
Store serum at 4C. Serum may be frozen, if needed.
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html,
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
Transport Medium None
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Contact Kathleen Tatti (404-639-3797, ket2@cdc.gov) or Dean Erdman
Include Specimen Handling (404-639-3727, dde1@cdc.gov) for shipping address.
Requirements
See the following link for additional shipping information:
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html

Methodology ELISA
Turnaround Time 3 Days
Interferences & Limitations Virus isolation in cell culture and initial characterization of viral agents
recovered in cultures of MERS-CoV specimens are NOT recommended at this
time. However, if done, these activities must be performed in a BSL-3 facility
using BSL-3 work practices.

Do not collect specimen in heparin tubes.


Additional lnformation http://www.cdc.gov/coronavirus/mers/index.html,
http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html,
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
CDC Points of Contact Kathleen Tatti
(404) 639-3797
ket2@cdc.gov
Dean Erdman
(404) 639-3727
dde1@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 225 of 363


Test Order
Microsporidia Molecular Identification
CDC-10481

Synonym(s) Anncaliia, Encephalitozoon cuniculi, Encephalitozoon hellem, Encephalitozoon


intestinalis, Septata intestinalis, Tubulinosema, Enterocytozoon bieneusi,
Nosema, Pleistophora, Trachipleistophora, Vittaforma corneae, Nosema
corneum, parasite
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Tissue, urine, stool (unpreserved or in a PCR-compatible preservative e.g. EcoFix,
Type for Testing UniFix, ZN-PVA, TotalFix, ethanol, potassium dichromate). Other specimen types
can be accepted after consultation and pre-approval.
Minimum Volume Required See Additional Information

Storage & Preservation of Storage and preservation is specimen specific


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship
Include Specimen Handling unpreserved specimen on wet ice (cold pack) as an etiologic agent.
Requirements Preserved/fixed specimens can be shipped at room temperature.
Methodology Conventional PCR
Turnaround Time 21 Days
Interferences & Limitations Stool specimens fixed in formalin-containing preservatives or LV-PVA are not
suitable for molecular studies.
Additional lnformation Minimum Volume Required: 0.5 g of stool or 1ml of urine or 25 mg tissue
CDC Points of Contact Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov
Marcos de Almeida
(404) 718-4126
bnz0@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 226 of 363


Test Order
Moraxella species ID
CDC-10140

Synonym(s) Moraxella, GNDC


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 227 of 363


Test Order
MPIR - Study
CDC-10428

Synonym(s) Anthrax TNA


Pre-Approval Needed Quinn, Conrad, (404) 639-2858, caq7@cdc.gov
Schiffer, Jarad, (404) 639-0894, aku3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Paired acute and convalescent sera


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Serum should be separated from whole blood and kept at -80C
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition including patient ID, date of
collection, submitter information, and specimen ID number.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Contact
Include Specimen Handling laboratory prior to shipment.
Requirements
Ship paired sera together and all frozen specimen should be shipped on dry ice
Methodology Cell Based Serological Assay
Turnaround Time 2 Weeks
Interferences & Limitations Prefer non-hemolyzed specimen and non-lipemic specimen. If they are
hemolyzed or lipemic, the specimen will not be tested. Plasma specimen are not
accepted. Do not store or send specimen in tubes with preservatives or cell
growth inhibitors.
Additional lnformation None
CDC Points of Contact Conrad Quinn
(404) 639-2858
caq7@cdc.gov
Jarad Schiffer
(404) 639-0894
aku3@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 228 of 363


Test Order
Mumps Detection (PCR) and Genotyping
CDC-10241

Synonym(s) None
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Buccal swab, nasal swab, throat swab, urine, oral fluid and cerebrospinal fluid
Type for Testing (CSF)
Minimum Volume Required Not Applicable

Storage & Preservation of See: http://www.cdc.gov/mumps/lab/specimen-collect.html for detailed


Specimen Prior to Shipping information on the storage and preservation of the specimen

Transport Medium http://www.cdc.gov/mumps/lab/


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which The laboratory requests that the sender contacts the laboratory by email or
Include Specimen Handling phone before shipping
Requirements
See shipping instructions: http://www.cdc.gov/mumps/lab/

Ship specimen Monday -Thursday overnight to avoid weekend deliveries

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on cold packs
Methodology Real time RT-PCR, Template production by RT-PCR, Viral culture, Genotyping by
Nucleic acid sequencing
Turnaround Time 7 Days
Interferences & Limitations See: http://www.cdc.gov/mumps/lab/ for information on the interferences and
limitations of this test
Additional lnformation Please include vaccination history, age, date of symptom onset and date of
sample collection

For additional information about mumps surveillance please see:


http://www.cdc.gov/vaccines/pubs/surv-manual/chpt09-mumps.html
CDC Points of Contact Paul Rota
(404) 639-4181
par1@cdc.gov
Rebecca McNall
(404) 639-4541
dqo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 229 of 363


Test Order
Mumps Neutralization Antibody (Not for Immune Status)
CDC-10351

Synonym(s) PRN test, Plaque-reduction neutralization


Pre-Approval Needed Sowers, Sun, (404) 639-1360, sib9@cdc.gov
Hickman, Carole, (404) 639-3339, cjh3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired serum


Type for Testing
Minimum Volume Required 300 uL

Storage & Preservation of Serum should be kept refrigerated, not frozen.


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Provide a unique identifier on the specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Neutralization assay - quantitative serological assay
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Sun Sowers
(404) 639-1360
sib9@cdc.gov
Carole Hickman
(404) 639-3339
cjh3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 230 of 363


Test Order
Mumps Serology
CDC-10245

Synonym(s) None
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 300 uL

Storage & Preservation of Serum should be kept refrigerated, not frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology CDC IgM Capture, Commercial indirect IgG
Turnaround Time 7 Days
Interferences & Limitations Rheumatoid factor, Parainfluenza viruses 1, 2, and 3, Epstein-Barr virus,
adenovirus, and Human Herpes Virus 6 have all been noted to interfere with
mumps serologic assays.
Additional lnformation IgM and IgG assays are qualitative assays

Please include vaccination history, age, date of onset and sample collection
CDC Points of Contact Nobia Williams
(404) 639-1049
new8@cdc.gov
Carole Hickman
(404) 639-3339
cjh3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 231 of 363


Test Order
Mumps Special Study
CDC-10252

Synonym(s) None
Pre-Approval Needed Hickman, Carole, (404) 639-3339, cjh3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Carole Hickman
(404) 639-3339
cjh3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 232 of 363


Test Order
Mycobacterium - Non-tuberculosis Mycobacteria Identification
CDC-10225

Synonym(s) Non-TB Mycobacteria, Mycobacteria


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates demonstrated to not be part of the Mycobacterium tuberculosis complex
Type for Testing Isolates from the following specimens will be accepted for testing:
Sterile sites (e.g., blood, CSF, body fluids)
Abscess, exudate or skin lesion
Wounds or surgical sites (see Additional Information)
BAL/ bronch wash
Sputum (see Additional Information)
Gastric lavage (pediatric)
Animal and environmental isolates with prior consultation
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen at room temperature


Specimen Prior to Shipping

Transport Medium Lowenstein-Jensen or Middlebrook 7H10/7H11 agar


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries at room
Include Specimen Handling temperature as an etiologic agent.
Requirements
Methodology 16S Sequencing, MALDI-TOF, Phenotypic Testing
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation Isolates from wounds or surgical sites must have documentation that NTM was
abundant on primary culture (3+ to 4+) or was the only organism isolated.
Isolates from sputum must have documentation that the NTM was from two or
more sputum cultures (collected on different days), was the only mycobacterial
species present, and have abundant growth on primary culture.
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Nadege Toney
(404) 639-1282
ngc6@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 233 of 363


Test Order
Mycobacterium TB Complex - Drug Susceptibility Testing
CDC-10185

Synonym(s) MTB DST, TB, Tuberculosis


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure isolate on solid medium or in broth culture


Type for Testing
Minimum Volume Required Not applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Broth should
Include Specimen Handling not be shipped frozen.
Requirements
Methodology Agar proportion, Pyrazinamide (PZA) by MGIT 960
Turnaround Time 32 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 234 of 363


Test Order
Mycobacterium TB Complex - Identification
CDC-10187

Synonym(s) TB, Tuberculosis


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolate


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements
Methodology Genetic based testing
Turnaround Time 14 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 235 of 363


Test Order
Mycobacterium TB Complex - Identification and Drug
Susceptibility Testing
CDC-10188
Synonym(s) TB, Tuberculosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure isolate on solid medium or in broth culture


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Broth should
Include Specimen Handling not be shipped frozen.
Requirements
Methodology Genetic based testing, Pyrazinamide (PZA) by MGIT 960, Agar Proportion
Turnaround Time 32 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 236 of 363


Test Order
Mycobacterium TB Complex - Identification and Pyrazinamide
Susceptibility Testing
CDC-10190
Synonym(s) TB, Tuberculosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure isolate on solid medium or in broth culture


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Broth should
Include Specimen Handling not be shipped frozen.
Requirements
Methodology Pyrazinamide (PZA) by MGIT 960, Genetic based testing
Turnaround Time 32 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 237 of 363


Test Order
Mycobacterium TB Complex - Molecular Detection of Drug
Resistance (MDDR)
CDC-10186
Synonym(s) MDDR, TB, Tuberculosis
Pre-Approval Needed Metchock, Beverly, (404) 639-2455, TBLab@cdc.gov
Driscoll, Jeff, (404) 639-2455, TBLab@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/tb/topic/laboratory/MDDRsubmissionform.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Nucleic Acid Amplification positive (NAA+) sputum sediment or pure culture
Type for Testing isolate on solid medium or in broth culture
Minimum Volume Required 0.5 mL (sediment)

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Sediments and
Include Specimen Handling broth cultures should not be shipped frozen.
Requirements
Methodology Pyrosequencing, Sanger sequencing, Agar Proportion DST, MGIT 960
Pyrazinamide (PZA)
Turnaround Time 3 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov
Jeff Driscoll
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 238 of 363


Test Order
Mycobacterium TB Complex - Pyrazinamide Susceptibility
Testing
CDC-10189
Synonym(s) PZA DST, TB, Tuberculosis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure isolate on solid medium or in broth culture


Type for Testing
Minimum Volume Required Not applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Mycobacterium tuberculosis (MTB) Growth Medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Broth should
Include Specimen Handling not be shipped frozen.
Requirements
Methodology Pyrazinamide (PZA) by MGIT 960
Turnaround Time 14 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 239 of 363


Test Order
Mycobacterium TB Complex - Special Study
CDC-10191

Synonym(s) None
Pre-Approval Needed Metchock, Beverly, (404) 639-2455, TBLab@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Beverly Metchock
(404) 639-2455
TBLab@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 240 of 363


Test Order
Mycobacterium TB Complex (International Only) Identification
and Drug Susceptibility Testing
CDC-10352
Synonym(s) Culture, DST, AST, MTB, MTB complex, TB, MDR TB, ID, Tuberculosis
Pre-Approval Needed Alexander, Heather, (404) 639-5331, drz5@cdc.gov
DeGruy, Kyle, (404) 639-0875, gsz4@cdc.gov
Supplemental Information Supplemental form will be provided upon consultation
Required
Fill out the ILB-100-F08C TB Requisition Form

CDC Form 0.753:


Application for Permit to Import or Transport Etiological Agents, Hosts, or
Vectors of
Human Disease. It is a requirement to complete this form.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Suspected Mycobacteria tuberculosis Complex isolates in Middlebrook 7H9 liquid
Type for Testing media or MGIT (7H9) broth inoculated with culture isolate
Minimum Volume Required 0.3 mL

Storage & Preservation of Mycobacterium tuberculosis Complex in Sterile 2.0 mL screw cap cryovial with
Specimen Prior to Shipping O-ring. Specimen should be kept frozen at -70C indefinitely, but specimen may
be stored at -20C for three months.
Transport Medium Middlebrook or MGIT (7H9) broth should be inoculated with a culture isolate of a
suspected Mycobacterium tuberculosis Complex and transported in a sterile 2.0
mL screw cap cryovial with O-ring.
Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which Keep specimen frozen at -70C or lower by using dry ice.
Include Specimen Handling
Requirements Refer to Mycobacterium tuberculosis Isolate Preparation & Shipments on page 7
of International Laboratory Branch Test Directory or contact laboratory prior to
submission.
Methodology Phenotypic and genotypic ID with reflex to drug susceptibility
Turnaround Time 150 Days
Interferences & Limitations Nonviable isolates sent for phenotypic DST and contaminated or mixed isolates
sent for phenotypic DST will interfere with the test.

Specimen can be rejected if improperly labeled or unlabeled, insufficient volume


for testing, without documentation or with discrepant documentation, and have
leaked in transit or otherwise show evidence of contamination.
Additional lnformation Turn around time is dependent on batch orders:

Batches with less than 100 specimens within 150 days


Batches with greater than 100, contact Heather Alexander, drz5@cdc.gov.

Tuesday, November 29, 2016 Version: 1.1 Page 241 of 363


Test Order
Mycobacterium TB Complex (International Only) Identification
and Drug Susceptibility Testing
CDC-10352

Drug Susceptibility Testing on Mycobacterium tuberculosis complex performed


for first line drugs streptomycin, isoniazid, rifampicin, ethambutol, and
pyrazinamide on the BD BACTECMGIT 960 system and for isoniazid and
rifampicin on molecular line probe assay. Drug Susceptibility Testing on
Mycobacterium tuberculosis complex performed for second line drugs with the
modified method of proportion for streptomycin, isoniazid, rifampicin,
ethambutol, rifabutin, PAS, ciprofloxacin, ofloxacin, kanamycin, ethionamide,
capreomycin, and amikacin. Genotype MTBDRsl tests second line drugs are
ofloxacin, ciprofloxacin, moxifloxacin, amikacin, kanamycin, capreomycin,
viomycin and ethambutol.
CDC Points of Contact Heather Alexander Zilma Rey
(404) 639-5331 (404) 639-2345
drz5@cdc.gov yzr0@cdc.gov
Kyle DeGruy
(404) 639-0875
gsz4@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 242 of 363


Test Order
Mycobacterium TB Complex (International Only) Special Study
CDC-10353

Synonym(s) None
Pre-Approval Needed Alexander, Heather, (404) 639-5331, drz5@cdc.gov
DeGruy, Kyle, (404) 639-0875, gsz4@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling All primary specimen containers must include 2 unique identifiers at the time of
collection. The identifiers must be clearly labeled on each specimen and
correspond to information on the requisition form.

Surveillance studies and some protocols require 1 unique identifier (the ILB
recommends 2 identifiers) de-linked from the patient. Do not include the
patients name or any other personally identifiable information. Results are not
reported back to patient.
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation
CDC Points of Contact Heather Alexander Zilma Rey
(404) 639-5331 (404) 639-2345
drz5@cdc.gov yzr0@cdc.gov
Kyle DeGruy
(404) 639-0875
gsz4@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 243 of 363


Test Order
Mycoplasma pneumoniae Molecular Detection
CDC-10155

Synonym(s) Walking pneumonia, Atypical pneumonia, Community Acquired Pneumoniae


(CAP)
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal (NP) and/or Oropharyngeal (OP) swabs, and any lower
Type for Testing respiratory tract specimen including bronchoalveolar lavage (BAL) and sputum;
tissue, cerebral spinal fluid , isolates and purified nucleic acid; Others upon
consultation with laboratory.
Minimum Volume Required Contingent upon specimen type. Please call for consultation

Storage & Preservation of Specimens can be kept refrigerated if shipped in less than 72 hours of collection;
Specimen Prior to Shipping otherwise specimen should be kept frozen. Store swabs in universal transport
medium.
Transport Medium Universal transport medium
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be sent on ice packs
Frozen specimen should be sent on dry ice
Methodology Real Time PCR
Turnaround Time 7 Days
Interferences & Limitations Do not use cotton swabs with wooden shafts. Specimen should be acquired prior
to antibiotic treatment. Improper specimen storage and handling may result in
inconclusive or inaccurate results.
Additional lnformation All specimens are tested as a part of a multiplex qPCR detecting M. pneumoniae,
C. pneumoniae, and Legionella species. See also CDC-10157
CDC Points of Contact Jonas Winchell
(404) 639-4921
Jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 244 of 363


Test Order
Mycoplasma species Study
CDC-10156

Synonym(s) None
Pre-Approval Needed Winchell, Jonas, (404) 639-4921, jwinchell@cdc.gov
Diaz, Maureen, (404) 639-4534, mdiaz1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Jonas Winchell
(404) 639-4921
jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 245 of 363


Test Order
Naegleria Molecular Detection
CDC-10482

Synonym(s) Free-living ameba, parasite


Pre-Approval Needed None
Supplemental Information Please provide the following information: history of present illness, exposure
Required history, past medical history, treatment history, CSF results, imaging results. If
images are available please upload to: http://www.cdc.gov/dpdx
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen For Naegleria fowleri molecular detection, CSF is the preferred specimen type. We
Type for Testing also accept fresh or frozen tissue for N. fowleri molecular detection. For
Acanthamoeba and Balamuthia molecular detection, tissue is the preferred
specimen type; however, these amebae can occasionally be detected in
cerebrospinal fluid (CSF).
Minimum Volume Required 1 mL CSF; 0.2 g tissue

Storage & Preservation of Storage and preservation is specimen specific


Specimen Prior to Shipping

Transport Medium Small piece of tissue should be transported in small amount of 0.5x PBS to
prevent dryness.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition. In addition to two patient identifiers
(sex, date of birth, name, etc.), provide specimen type and date of collection.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Please contact
Include Specimen Handling laboratory prior to shipping any specimen and include unit 53 on the outside of
Requirements package. Ship specimen at room temperature, not on dry ice, as an etiologic
agent, unless the specimen has been previously frozen. Frozen specimens may
be shipped in cold with ice packs. Please send the shipment tracking number on
the day of shipment by e-mail to the CDC Point of Contacts (see below).
Methodology Real-Time PCR
Turnaround Time 7 Days
Interferences & Limitations Formalin-fixed specimens are not suitable for molecular studies as formalin
fixation may cause DNA degradation. Fresh or frozen specimens, if available, are
preferred over the formalin-fixed specimens.
Additional lnformation None
CDC Points of Contact Jennifer Cope
(404) 718-4878
bjt9@cdc.gov
Ibne Ali
(404) 718-4157
xzn5@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 246 of 363


Test Order
NARMS Susceptibility Testing
CDC-10107

Synonym(s) National Antimicrobial Resistance Monitoring System, NARMS surveillance


Pre-Approval Needed None
Supplemental Information Submitter must be a NARMS participating laboratory. Specimens accepted
Required according to current National Antimicrobial Resistance Monitoring System
(NARMS) sampling scheme. NARMS log sheet or entry into NARMS web
interface.
Supplemental Form https://wwwn.cdc.gov/NARMS/UserLogin.aspx
Performed on Specimens From Human

Acceptable Sample/ Specimen Isolates. Specimens accepted according to NARMS guidelines


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Please refer to guidance for specific organism


Specimen Labeling State or local public health laboratory number
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Please refer to guidance for specific organism.
Methodology Broth Microdilution Antimicrobial Susceptibility (AST), E-Test Susceptibility
Testing
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation The turn around time depends on the nature of subtyping performed; and,
results are typically reported directly to the surveillance databases.
CDC Points of Contact Christina Scheel
(404) 639-3126
zsr3@cdc.gov
Jason Foster
(404) 639-4948
gux8@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 247 of 363


Test Order
Neisseria (STD) Identification
CDC-10101

Synonym(s) Neisseria, GC
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Genital, pharyngeal, and/or rectal swabs. In addition, bacterial culture or isolate
Type for Testing on appropriate culture media
Minimum Volume Required Not Applicable

Storage & Preservation of Specimen needs to be stored in a manner that will maintain viability of
Specimen Prior to Shipping gonorrhea

Transport Medium Any acceptable medium for gonorrhea transport


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.
Methodology Phenotypic identification
Turnaround Time 1 Week
Interferences & Limitations Anything that can affect viability of gonorrhea will adversely affect the test
results
Additional lnformation Please provide information on any antibiotics the patient may have been treated
with
CDC Points of Contact John Papp
(404) 639-3785
jwp6@cdc.gov
Kevin Pettus
(404) 639-4338
kbp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 248 of 363


Test Order
Neisseria gonorrhoeae Study
CDC-10103

Synonym(s) None
Pre-Approval Needed Papp, John, (404) 639-3785, jwp6@cdc.gov
Pettus, Kevin, (404) 639-4338, kbp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact John Papp
(404) 639-3785
jwp6@cdc.gov
Kevin Pettus
(404) 639-4338
kbp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 249 of 363


Test Order
Neisseria gonorrhoeae Susceptibility Testing
CDC-10102

Synonym(s) Neisseria AST, GC Susceptibility


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Genital, pharyngeal, and/or rectal swabs. In addition, bacterial culture or isolate
Type for Testing on appropriate growth media
Minimum Volume Required Not Applicable

Storage & Preservation of Specimen needs to be stored in a manner that will maintain viability of
Specimen Prior to Shipping gonorrhea

Transport Medium Any acceptable medium for gonorrhea transport


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.
Methodology Agar Plate Dilution, E-test, Disk Diffusion
Turnaround Time 4 Weeks
Interferences & Limitations Anything that can affect viability of gonorrhea will adversely affect the test
results
Additional lnformation Please provide information on any antibiotics the patient may have been treated
with
CDC Points of Contact John Papp
(404) 639-3785
jwp6@cdc.gov
Kevin Pettus
(404) 639-4338
kbp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 250 of 363


Test Order
Neisseria meningitidis Identification and Serogrouping
CDC-10219

Synonym(s) N. meningitidis ID and SASG, Nm


Pre-Approval Needed None
Supplemental Information If tested and known, please include lab results with methods used (including
Required manufacturer of antiserum) in previous lab results section of submission form.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolate, frozen stock, primary specimen such as CSF, whole blood,
Type for Testing serum, and other sterile site specimen types upon consultation.
Minimum Volume Required 0.25 mL

Storage & Preservation of Primary specimens or stocks should be kept frozen. After overnight incubation at
Specimen Prior to Shipping 37C with 5% CO2, store slants at an ambient temperature.

Transport Medium Preferred medium include chocolate agar slants or frozen stocks. If possible, for
the shipment of 10 or more specimens, please ship frozen stocks.
Specimen Labeling Tests subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition. Label ABCs/Enhanced Surveillance specimens
with the state ID & accession number.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Frozen specimens should be shipped on dry ice. Please include shipping
spreadsheet in shipment and if possible, email spreadsheet prior to shipment.
Methodology Growth, Morphology, Biochemical Testing, Slide Agglutination Serogrouping,
Real-time PCR
Turnaround Time 30 Days
Interferences & Limitations Improperly temperature controlled specimens/isolates can give false negative
results.
Additional lnformation Turnaround time: 30 days for real-time PCR testing of clinical specimens; 90
days for testing of enhanced surveillance submissions
CDC Points of Contact Melissa Whaley Meningitis Laboratory
(404) 639-3920 (404) 639-5009
dbq3@cdc.gov
Laurel T. Jenkins
(404) 639-1340
knt9@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 251 of 363


Test Order
Neisseria meningitidis Study
CDC-10220

Synonym(s) Nm Study
Pre-Approval Needed Wang, Xin, (404) 639-5474, gqe8@cdc.gov
Briere, Elizabeth, (404) 639-0732, ejc0@cdc.gov
Supplemental Information Brief description of study or surveillance program.
Required
Supplemental Form Required: CDC Meningitis Laboratory: Molecular Typing
Request Submission Form (provided upon request by CDC Meningitis
Laboratory).

Supplemental Form
Performed on Specimens From Human

Acceptable Sample/ Specimen Pure culture isolate or frozen stock. If no viable isolate is available and bacterial
Type for Testing DNA is detected, submit frozen primary specimens.
Minimum Volume Required N/A

Storage & Preservation of Primary specimens or stocks should be kept frozen. After overnight incubation at
Specimen Prior to Shipping 37C with 5% CO2, store slants at an ambient temperature.

Transport Medium Chocolate agar slants or frozen stocks.


Specimen Labeling Tests subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries.
Include Specimen Handling
Requirements Frozen specimens should be shipped on dry ice. Please include shipping
spreadsheet in shipment and if possible, email spreadsheet prior to shipment.
Methodology Multilocus Sequence Typing (MLST), Whole Genome Sequencing (WGS)
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Xin Wang
(404) 639-5474
gqe8@cdc.gov
Melissa Whaley
(404) 639-3920
dbq3@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 252 of 363


Test Order
Neisseria species (Not GC or meningococcus) ID
CDC-10139

Synonym(s) Neisseria, GNDC


Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 253 of 363


Test Order
Nipah Virus Identification
CDC-10354

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 254 of 363


Test Order
Nipah Virus Serology
CDC-10355

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 255 of 363


Test Order
Nocardia species ID
CDC-10150

Synonym(s) None
Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 256 of 363


Test Order
Nocardia species ID and AST
CDC-10151

Synonym(s) None
Pre-Approval Needed None
Supplemental Information Please notify laboratory prior to shipment if this is a critical care specimen
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; consultation required for
Type for Testing other sample/specimen types
Minimum Volume Required Not Applicable

Storage & Preservation of Keep specimen refrigerated if unable to ship immediately


Specimen Prior to Shipping

Transport Medium Suitable agar slant medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements
Methodology Primary Culture based on specimen type, MALDI-TOF, 16S sequence based
identification, AST by broth microdilution
Turnaround Time 3 Weeks
Interferences & Limitations The 3 week turnaround time applies to all tests unless biochemical and/or
phenotypic analysis are required, which could take up to 2 months for test
results.
Additional lnformation If available, please provide patient history including if the patient has used a
catheter and/or if the patient is immunocompromised.
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 257 of 363


Test Order
Norovirus Genotyping
CDC-10356

Synonym(s) Norovirus
Pre-Approval Needed Vinje, Jan, (404) 639-3721, ahx8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool, environmental swab


Type for Testing
Minimum Volume Required 0.25 g or 0.25 mL

Storage & Preservation of Specimen must be stored at 2-8C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Jan Vinje
(404) 639-3721
ahx8@cdc.gov
Leslie Barclay
(404) 639-1159
gvm3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 258 of 363


Test Order
Norovirus Molecular Detection
CDC-10357

Synonym(s) Norovirus
Pre-Approval Needed Vinje, Jan, (404) 639-3721, ahx8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool, environmental swab


Type for Testing
Minimum Volume Required 0.25 g or 0.25 mL

Storage & Preservation of Specimen should be stored at 2-8C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Jan Vinje
(404) 639-3721
ahx8@cdc.gov
Leslie Barclay
(404) 639-1159
gvm3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 259 of 363


Test Order
Norovirus Molecular Detection and Genotyping
CDC-10358

Synonym(s) Norovirus
Pre-Approval Needed Vinje, Jan, (404) 639-3721, ahx8@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool, environmental swab


Type for Testing
Minimum Volume Required 0.25 g or 0.25 mL

Storage & Preservation of Specimen must be stored at 2-8C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Jan Vinje
(404) 639-3721
ahx8@cdc.gov
Leslie Barclay
(404) 639-1159
gvm3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 260 of 363


Test Order
Orientia Molecular Detection
CDC-10359

Synonym(s) Scrub Typhus


Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Acute samples only, anticoagulated whole blood collected in
Type for Testing Ethylenediaminetetraacetic acid (EDTA) treated tubes preferred; serum; fresh
tissue biopsy
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Ethylenediaminetetraacetic acid (EDTA) blood tubes for blood; tissue in a sample
collection tube
Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Real Time Polymerase Chain Reaction (PCR), Polymerase Chain Reaction (PCR),
Sequencing
Turnaround Time 6 Weeks
Interferences & Limitations Hemolysis in whole blood specimen will interfere with results. Multiple freeze
thaw cycles and sample storage above refrigerated temperatures will interfere
with proper nucleic acid extraction. If a specimen is drawn at convalescence it
will reduce the chance of the target organism being present in blood. Avoid
collection of blood specimen in heparin tubes.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 261 of 363


Test Order
Orientia Serology
CDC-10360

Synonym(s) Scrub Typhus


Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Indirect Fluorescence Assay (IFA)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact laboratory prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial lab.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 262 of 363


Test Order
Orientia Special Study
CDC-10500

Synonym(s) Scrub typhus


Pre-Approval Needed Kato, Cecilia, (404) 639-0152, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Molecular detection, Serology, Culture, Immunohistochemistry (IHC), Other
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cecilia Kato
(404) 639-0152
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 263 of 363


Test Order
Paragonimiasis Serology
CDC-10465

Synonym(s) Paragonimus westermani; Paragonimus kellicotti, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and previous test results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology Immunoblot, Western Blot, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 264 of 363


Test Order
Parasite - Morphologic Identification (O+P)
CDC-10234

Synonym(s) Parasitology, Malaria parasite identification, Blood parasite, ova and parasite
Pre-Approval Needed None
Supplemental Information Supplemental form not needed
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool specimens, blood, and tissue. Additional acceptable specimens are listed
Type for Testing on the supplemental link.
Minimum Volume Required Not Applicable

Storage & Preservation of Storage and preservation is specimen specific, see supplemental link
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries
Include Specimen Handling Shipping is specimen specific see supplemental link
Requirements
Methodology Microscopy
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Henry Bishop
(404) 718-4102
hsb2@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 265 of 363


Test Order
Parasite - Special Study
CDC-10237

Synonym(s) None
Pre-Approval Needed McAuliffe, Isabel, (404) 718-4100, ibm4@cdc.gov
Qvarnstrom, Yvonne, (404) 718-4123, bvp2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
Yvonne Qvarnstrom
(404) 718-4123
bvp2@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 266 of 363


Test Order
Parechovirus Detection and Identification
CDC-10362

Synonym(s) Human parechovirus, HPEV, Echovirus 22, Echovirus 23, Ljungan virus,
parechovirus
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Specimens include stool, serum, throat or nasal swab, cerebrospinal fluid (CSF),
Type for Testing vesicle fluid or lesion, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs.
Fresh or frozen tissues are preferred to Formalin fixed tissues, but will accept
both.
Minimum Volume Required Not Applicable

Storage & Preservation of Vesicle fluid, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs:
Specimen Prior to Shipping Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays. Place the swab immediately into a sterile viral containing 2mL of viral
transport media without antibiotics, if possible.

Stool: Collect in a clean, dry, leak-proof container.

Serum: For each serum specimen, collect whole blood into a serum separator
tube (marble or tiger top SST). Allow to clot at room temperature for a minimum
of 30 minutes and centrifuge.
Transport Medium Viral transport medium. If you do not have viral transport media, place the swab
into a sterile vial without viral transport media. Aseptically, cut or break
applicator sticks off near the tip to permit tightening of the cap. For NP/OP
swabs, both swabs can be placed in the same vial, if desired.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.

Include the full name, title, complete mailing address, email address, telephone,
and fax number of the submitter. This will be the person to whom the final
report will be mailed to.
Methodology Molecular techniques
Turnaround Time 14 Days
Interferences & Limitations Collecting specimens during the first week of illness is ideal although the virus
can be shed in stool for several weeks. A specimen set collected in the second
week of illness should include a rectal swab or stool sample.
Additional lnformation Minimum volume for cell culture is 0.5-1 mL, for CSF is 60 uL, and for fresh
frozen tissues is 2 mm^2.

Stool: Stool may be collected within 14 days of symptom onset. Collect 10-20 g
of stool in a clean, dry, leak-proof container.

Tuesday, November 29, 2016 Version: 1.1 Page 267 of 363


Test Order
Parechovirus Detection and Identification
CDC-10362

Serum: For each serum specimen, collect (adults and children >6kg: 5 mL,
children <6 kg: 2 mL) of whole blood into a serum separator tube (marble or
tiger top SST). A minimum of 1 mL of whole blood is needed for testing of
pediatric patients. Allow to clot at room temperature for a minimum of 30
minutes and centrifuge.
CDC Points of Contact Alan Nix
(404) 639-1689
wbn0@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 268 of 363


Test Order
Parvovirus B Molecular Detection
CDC-10363

Synonym(s) Fifth Disease


Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, blood, plasma, and amniotic fluid


Type for Testing
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate all specimens promptly after collection. If specimens can be shipped
Specimen Prior to Shipping to CDC within 72 hours of collection, they should be kept refrigerated at 4C and
shipped on gel ice-packs. If specimens must be held for >72 hours, they should
be promptly frozen at -70C and shipped on dry ice. Liquid specimens should be
aliquoted into properly labeled, leak-proof, unbreakable screw cap vials.
Samples should be collected and processed in a manner that prevents cross-
contamination between specimens, including changing gloves between
specimens.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Frozen specimen should be shipped on dry ice
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 3 Weeks
Interferences & Limitations Do not use wooden-shafted swabs or calcium alginate swabs
Additional lnformation None
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 269 of 363


Test Order
Parvovirus B Serology
CDC-10364

Synonym(s) Fifth Disease


Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate all specimens promptly after collection. If specimens can be shipped
Specimen Prior to Shipping to CDC within 72 hours of collection, they should be kept refrigerated at 4C and
shipped on gel ice-packs. If specimens must be held for >72 hours, they should
be promptly frozen at -70C and shipped on dry ice. Liquid specimens should be
aliquoted into properly labeled, leak-proof, unbreakable screw cap vials.
Samples should be collected and processed in a manner that prevents cross-
contamination between specimens, including changing gloves between
specimens.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology IgG and IgM enzyme immunoassay
Turnaround Time 3 Weeks
Interferences & Limitations Do not collect in heparin tubes
Additional lnformation None
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 270 of 363


Test Order
Pathologic Evaluation of Tissues for Possible Infectious
Etiologies
CDC-10365
Synonym(s) Autopsy, biopsy, formalin fixed tissues, FFPE, pathology, paraffin blocks,
histopathology, electron microscopy, immunohistochemistry, PCR
Pre-Approval Needed Infectious Disease Pathology Branch, , (404) 639-3132, pathology@cdc.gov
Supplemental Information Please include the following information with each submission:
Required - The full name, title, complete mailing address, e-mail address, and
telephone and fax numbers of the submitter. This will be the same person to
whom the final pathology report is addressed.
- A completed CDC Form 50.34
- A cover letter outlining a brief clinical history, including relevant
demographic/epidemiologic information; a copy of (a) the autopsy report
(preliminary or final) or (b) surgical pathology report; copies of pertinent
laboratory results (microbiology, hematology, serology, culture, and/or
biochemical); images (clinical and/or gross autopsy photos).

Please include a key to the identification of the blocks


Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Paraffin-embedded tissue blocks, formalin-fixed tissues, unstained glass slides,
Type for Testing electron microscopy grids or blocks. Frozen tissues may be acceptable in some
circumstances and will not be accepted without pre-approval.

More specific guidelines regarding tissue samples and submission can be found
on the IDPB website:
http://www.cdc.gov/ncezid/dhcpp/idpb/specimen-submission/index.html
Minimum Volume Required Not Applicable

Storage & Preservation of Consultation with IDPB is required prior to specimen submission to determine
Specimen Prior to Shipping appropriate storage and preservation conditions. In general, wet tissues should
be submitted in 10% neutral buffered formalin after adequate fixation; wet
tissues and paraffin-embedded tissues should be preserved at ambient
temperature; unstained slides should be sectioned at 3-5 microns; specimens
submitted for electron microscopy should be fixed in glutaraldehyde and held in
phosphate buffer.
Transport Medium Electron microscopy specimens should be fixed in glutaraldehyde and held in
phosphate buffer and sent on wet ice. Do not freeze.
Specimen Labeling All submitted specimens should be labeled with at least two identifiers. The
tissues contained within paraffin-embedded blocks should be clearly indicated
on submitted paperwork.
Shipping Instructions which Ship specimens overnight from Monday-Thursday. For urgent cases, please
Include Specimen Handling contact the pathology laboratory immediately. During hot weather, tissue blocks
Requirements should be shipped on ice packs to prevent the melting of paraffin. Fresh frozen
tissues can only be submitted with pre-approval and should not be submitted in
the same package as fixed tissues or paraffin blocks.

The full name, title, complete mailing address, e-mail address, telephone and
fax numbers are required for each submitted specimen. This will be to whom the
final pathology report is addressed.
Methodology Histopathology (H&E-stained sections), Cytochemistry (special stains),
Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR) and Sequencing,

Tuesday, November 29, 2016 Version: 2.0 Page 271 of 363


Test Order
Pathologic Evaluation of Tissues for Possible Infectious
Etiologies
CDC-10365
Electron Microscopy (EM), Tissue Culture, Nucleic Acid Extraction for transfer to
other branches
Turnaround Time 6 Weeks
Interferences & Limitations Prolonged fixation (>2 weeks) may interfere with some immunohistochemical
and molecular diagnostic assays
Additional lnformation More specific guidelines regarding tissue sampling and submission can be found
on the IDPB website:
http://www.cdc.gov/ncezid/dhcpp/idpb/specimen-submission/index.html

Turnaround time varies depending upon the complexity of each case, but is
approximately 2-6 weeks.

Digital images can be provided to assist in evaluation and guide testing.


CDC Points of Contact Infectious Disease Pathology Branch
(404) 639-3132
pathology@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 272 of 363


Test Order
Pathology Special Study
CDC-10373

Synonym(s) None
Pre-Approval Needed Pathology Branch, , (404) 639-3132, pathology@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology To be determined
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Pathology Branch
(404) 639-3132
pathology@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 273 of 363


Test Order
Picornavirus Detection and Identification (not Hepatitis A, not
Rhinovirus)
CDC-10374
Synonym(s) Theier's murine encephalomyelitis virus (TMEV), Saffold virus (SAFV), Cosavirus
(COSV) (Dekavirus), Salivirus (SALV) (Klassevirus), Kobuvirus, Aichi virus,
Encephalomyocarditis virus (EMCV), Vilyuisk virus
Pre-Approval Needed Nix, Alan, (404) 639-1689, wbn0@cdc.gov
Oberste, Steve, (404) 639-5497, mbo2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Specimens include stool, serum, throat or nasal swab, cerebrospinal fluid (CSF),
Type for Testing vesicle fluid or lesion, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs.
Fresh or frozen tissues are preferred to Formalin fixed tissues, but will accept
both.
Minimum Volume Required Not Applicable

Storage & Preservation of Vesicle fluid, rectal, or nasopharyngeal (NP)/oropharyngeal (OP) swabs:
Specimen Prior to Shipping Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. DO NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays. Place the swab immediately into a sterile viral containing 2mL of viral
transport media without antibiotics, if possible.

Stool: Collect in a clean, dry, leak-proof container.

Serum: For each serum specimen, collect whole blood into a serum separator
tube (marble or tiger top SST). Allow to clot at room temperature for a minimum
of 30 minutes and centrifuge.
Transport Medium Viral transport medium. If you do not have viral transport media, place the swab
into a sterile vial without viral transport media. Aseptically, cut or break
applicator sticks off near the tip to permit tightening of the cap. For NP/OP
swabs, both swabs can be placed in the same vial, if desired.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.

Include the full name, title, complete mailing address, email address, telephone,
and fax number of the submitter. This will be the person to whom the final
report will be mailed to.
Methodology Molecular techniques
Turnaround Time 14 Days
Interferences & Limitations Collecting specimens during the first week of illness is ideal although the virus
can be shed in stool for several weeks. A specimen set collected in the second
week of illness should include a rectal swab or stool sample.
Additional lnformation Minimum volume for cell culture is 0.5-1 mL, for CSF is 60 uL, and for fresh
frozen tissues is 2 mm^2.

Tuesday, November 29, 2016 Version: 1.0 Page 274 of 363


Test Order
Picornavirus Detection and Identification (not Hepatitis A, not
Rhinovirus)
CDC-10374
Stool: Stool may be collected within 14 days of symptom onset. Collect 10-20 g
of stool in a clean, dry, leak-proof container.

Serum: For each serum specimen, collect (adults and children >6 kg: 5 mL,
children <6 kg: 2 mL) of whole blood into a serum separator tube (marble or
tiger top SST). A minimum of 1 mL of whole blood is needed for testing of
pediatric patients. Allow to clot at room temperature for a minimum of 30
minutes and centrifuge.
CDC Points of Contact Alan Nix
(404) 639-1689
wbn0@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 275 of 363


Test Order
Picornavirus Special Study
CDC-10375

Synonym(s) None
Pre-Approval Needed Nix, Alan, (404) 639-1689, wbn0@cdc.gov
Oberste, Steve, (404) 639-5497, mbo2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Alan Nix
(404) 639-1689
wbn0@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 276 of 363


Test Order
Polio Isolation and Genotyping
CDC-10376

Synonym(s) PV, polio virus, Polio sequencing, AFP, acute flaccid paralysis
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Stool, tissue culture, isolate, Fast Technology for Analysis of nucleic acids (FTA)
Type for Testing cards, less common clinical specimens include nasopharyngeal and rectal swabs
and cerebrospinal fluid (CSF)
Minimum Volume Required 50 uL (tissue culture)

Storage & Preservation of Keep specimen refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.
Methodology Molecular techniques, Cell culture
Turnaround Time 21 Days
Interferences & Limitations None
Additional lnformation If case investigation form is readily available, please submit with specimen
CDC Points of Contact Cara Burns
(404) 639-5499
zqd1@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 277 of 363


Test Order
Polio Serology
CDC-10377

Synonym(s) Neutralization assay, NT, MNT


Pre-Approval Needed Weldon, William, (404) 639-5485, wiw4@cdc.gov
Oberste, Steve, (404) 639-5497, mbo2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Needs to be collected from clotted whole blood or through serum separated
Specimen Prior to Shipping tubes (SST). Serum needs to be frozen.

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice as an etiologic agent.
Requirements
Methodology Neutralization assay
Turnaround Time 4 Weeks
Interferences & Limitations Red blood cell hemolysis will adversely affect test results
Additional lnformation None
CDC Points of Contact William Weldon
(404) 639-5485
wiw4@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 278 of 363


Test Order
Polio Special Study
CDC-10378

Synonym(s) None
Pre-Approval Needed Burns, Cara, (404) 639-5499, zqd1@cdc.gov
Oberste, Steve, (404) 639-5497, mbo2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cara Burns
(404) 639-5499
zqd1@cdc.gov
Steve Oberste
(404) 639-5497
mbo2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 279 of 363


Test Order
Poxvirus - Cowpox Specific Molecular Detection
CDC-10379

Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 280 of 363


Test Order
Poxvirus - Encephalitis Work-Up (Post Vaccinia Encephalitis,
Monkeypox, etc.)
CDC-10380
Synonym(s) Monkeypox, Post-vaccinial encephalitis
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Cerebrospinal fluid (CSF) and serum must be submitted
Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Keep specimen refrigerated. Serum should be collected in a venous blood tube
Specimen Prior to Shipping containing a clot activator and/or gel. Blood tubes should be spun prior to
shipment or an aliquot of the collected serum can be shipped.
Transport Medium Not Applicable
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology ELISA, Real Time PCR
Turnaround Time 2 Days
Interferences & Limitations In order to accurately interpret test results generated from CSF specimens,
paired serum must be submitted
Additional lnformation Turnaround time:
Urgent cases
- Testing is completed within 48 hours of specimen receipt when results directly
impact patient care;
Routine cases
- Testing is completed within 5-7 days of specimen receipt.
For serology testing, please notify the lab prior to shipment so reagents can be
prepared
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 281 of 363


Test Order
Poxvirus - Molluscum Contagiosum Specific Molecular
Detection
CDC-10381
Synonym(s) MCV
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.1 Page 282 of 363


Test Order
Poxvirus - Monkeypox Specific Molecular Detection
CDC-10382

Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material.
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 1.0 Page 283 of 363


Test Order
Poxvirus - Orthopoxvirus Serology (Includes Vaccinia virus)
CDC-10384

Synonym(s) Orthopoxvirus, Vaccincia Antibody detection


Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum Sample


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Keep specimen refrigerated. Serum should be collected in a venous blood tube
Specimen Prior to Shipping containing a clot activator and/or gel. Blood tubes should be spun prior to
shipment or an aliquot of the collected serum can be shipped.
Transport Medium Not Applicable
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology ELISA
Turnaround Time 2 Days
Interferences & Limitations Collection in either heparin and/or EDTA will interfere with results
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed within 48 hours of specimen receipt when results directly
impact patient care;
Routine cases
-Testing is completed within 5-7 days of specimen receipt.
For serology testing, please notify the lab prior to shipment so reagents can be
prepared
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 1.0 Page 284 of 363


Test Order
Poxvirus - Pan-Poxvirus Molecular Detection (Human
Infections)
CDC-10385
Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material.
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 2 Days
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 285 of 363


Test Order
Poxvirus - Parapoxvirus Generic Molecular Detection
CDC-10383

Synonym(s) Sore mouth, scabby mouth, contagious ecthyma


Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.1 Page 286 of 363


Test Order
Poxvirus - Parapoxvirus Molecular Detection
CDC-10386

Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 287 of 363


Test Order
Poxvirus - Sealpox Specific Molecular Detection
CDC-10387

Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 288 of 363


Test Order
Poxvirus - Smallpox (Variola Virus) Specific Molecular
Detection
CDC-10388
Synonym(s) None
Pre-Approval Needed DEOC, , (770) 488-7100,
Supplemental Information Call CDC Emergency Operations Center prior to contacting laboratory
Required 770-488-7100
Supplemental Form http://www.bt.cdc.gov/agent/smallpox/
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material, serum, and blood must all be submitted. Lesion
Type for Testing fluid and/or material: vesicle / pustule skin or fluid, scab, crust, etc.; collection
method: touch prep slide, swab, biopsy
Minimum Volume Required 1 mL (blood and serum)

Storage & Preservation of Serum should be collected in a venous blood tube containing a clot activator
Specimen Prior to Shipping and/or gel. Blood tubes should be spun prior to shipment or an aliquot of the
collected serum can be shipped. Whole blood should be collected in a blood tube
containing ethylenediaminetetraacetic acid (EDTA).

Keep specimen refrigerated. It is extremely important not to cross-contaminate


specimens (i.e., one specimen per container). Viral transport media should not
be added to specimens. All specimens should be stored at 4C until shipment.
Swabs without individual holders may be stored in a sterile container.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Approval must be obtained prior to the shipment of potential smallpox patient
Include Specimen Handling clinical specimens to CDC
Requirements
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Cotton swabs may cause PCR inhibition and should not be used. Heparin may
cause PCR inhibition and should not be used to collect whole blood.
Additional lnformation A suspected case of smallpox must be immediately reported to appropriate local,
state, or territorial health departments. After review, if smallpox is still
suspected, the case should be immediately reported to CDCs Emergency
Operations Center.

Specimens should be collected as outlined in Guide D on the CDC website:


Http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-d.pdf
CDC Points of Contact DEOC
(770) 488-7100

Tuesday, November 29, 2016 Version: 1.0 Page 289 of 363


Test Order
Poxvirus - Tanapox Specific Molecular Detection
CDC-10389

Synonym(s) None
Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 290 of 363


Test Order
Poxvirus - Vaccinia Specific Molecular Detection
CDC-10390

Synonym(s) Smallpox Vaccine


Pre-Approval Needed Help Desk, , (404) 639-4129,
Supplemental Information Clinical consultation with the Poxvirus Program is required prior to specimen
Required shipment to determine testing urgency. A supplemental form will be supplied
after initial consultation.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Lesion fluid and/or material: vesicle/pustule skin or fluid, scab, crust, etc.
Type for Testing Collection method: fresh or frozen, swab, biopsy, touch prep slides, formalin
fixed, paraffin block. Swabs should be made of nylon, polyester, or Dacron
material.
Minimum Volume Required Not Applicable

Storage & Preservation of All specimens should be stored at 4C until shipment. Swabs without individual
Specimen Prior to Shipping holders may be stored in a sterile container. Dry swabs are preferred but a
minimal amount of viral transport media may be added.
Transport Medium Prefer swabs dry but will accept specimen in a minimum viral transport medium
Specimen Labeling Test requires two patient identifiers on the specimen container and the test
requisition. In addition to two patient identifiers (name, date of birth/age, etc.),
provide specimen type, date of
collection and body location.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Methodology Real Time-PCR
Turnaround Time 1 Day
Interferences & Limitations Swabs intended for the collection and transport of bacterial specimens should
not be used. Cotton swabs may cause PCR inhibition and should not be used.
The addition of viral transport media to swab specimens will dilute any viral DNA
present.
Additional lnformation Turnaround time:
Urgent cases
-Testing is completed and reported within 24 hours of specimen receipt when
results directly impact patient care;
Routine cases
-Testing is completed and reported within 5 business days of specimen receipt.
Formalin fixed material is first tested by the Infectious Disease Pathology Branch
(IDPB) and will only identify poxviruses to the genus level. DNA may be extracted
from paraffin block embedded lesion material and tested by the Poxvirus
Program. Fresh, non-frozen tissue is preferred by IDPB.
CDC Points of Contact Help Desk
(404) 639-4129

Tuesday, November 29, 2016 Version: 2.0 Page 291 of 363


Test Order
Puumala Serology
CDC-10391

Synonym(s) Hanta, HFRS, Nephropathia epidemica


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 292 of 363


Test Order
Rabies Antemortem Human Testing
CDC-10392

Synonym(s) None
Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen All four of the following are required for testing: serum, CSF, nuchal (skin)
Type for Testing biopsy, and saliva
Minimum Volume Required 500 uL (serum, CSF, saliva)

Storage & Preservation of Keep all samples stored at -80C and ship on dry ice. Serum and CSF can be
Specimen Prior to Shipping refrigerated before shipping. Please see the supplemental link for specific
specimen storage and preservation.
Transport Medium Saliva and Nuchal (skin) biopsy should not be put in a transport medium
Specimen Labeling Two patient identifiers on the specimen container and the test requisition,
sample type and date of collection
Shipping Instructions which Ship all specimens overnight, first AM delivery and provide the CDC Point of
Include Specimen Handling Contact with the tracking number of package.
Requirements
Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs

Form 50.34 is required for each of the 4 samples (serum, CSF, skin biopsy, and
saliva)
Methodology IgG by IFA (Serum and CSF), IgM by IFA (Serum and CSF), Viral Neutralizing
Antibodies by RFFIT (Serum and CSF), DFA (Nuchal (skin) biopsy), RT-PCR
(Nuchal (skin) biopsy), RT-PCR (Saliva), Sequencing
Turnaround Time 5 Days
Interferences & Limitations Saliva and CSF specimen should be free of blood because blood may interfere
with test results due to the inhibitors present in blood
Additional lnformation Sequencing will only be performed if the RT-PCR test is positive. Nuchal (skin)
biopsy has to be a full punch (5-6 millimeters). If testing needs to be repeated
results may take up to 7 days.
CDC Points of Contact Rabie Duty Officer
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.2 Page 293 of 363


Test Order
Rabies Antibody - Pre/Post-exposure Prophylaxis
CDC-10393

Synonym(s) Serology, Immunization status, Rabies titer


Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/rabies/pdf/rorform.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 500 uL

Storage & Preservation of Specimen can be kept refrigerated but prefer frozen
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Two patient identifiers on the specimen container and the test requisition,
sample type and date of collection
Shipping Instructions which Ship all specimens overnight, first AM delivery and provide the CDC Point of
Include Specimen Handling Contact with the tracking number of package.
Requirements
Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Viral Neutralizing Antibodies RFFIT
Turnaround Time 3 Days
Interferences & Limitations Hemolyzed samples interfere with test results
Additional lnformation If testing needs to be repeated results may take up to 7 days
CDC Points of Contact Rabies Duty Officer
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.1 Page 294 of 363


Test Order
Rabies Confirmatory Testing (Animal)
CDC-10394

Synonym(s) Rabies DFA


Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Animal

Acceptable Sample/ Specimen Fresh-frozen brain tissues: full cross section of brain stem and cerebellum
Type for Testing (vermis, right and left lateral lobes). Other specimens may be submitted upon
consultation with Rabies Duty Officer.
Minimum Volume Required Not Applicable

Storage & Preservation of Stored at -80C and should be kept on dry ice
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling One patient identifier on the specimen container and the test requisition,
sample type and date of collection
Shipping Instructions which Ship all specimens overnight, first AM delivery and provide the CDC Point of
Include Specimen Handling Contact with the tracking number of package
Requirements
Frozen specimen should be shipped on dry ice
Methodology DFA for rabies virus antigen, Direct Rapid Immunohistochemistry test (DRIT),
Real Time RT-PCR, Virus Isolation, Antigenic Typing, Sequence Analysis
Turnaround Time 3 Days
Interferences & Limitations Test is limited by decomposed tissues due to denaturation of viral proteins
Additional lnformation May take up longer if repeat testing and additional procedures are required to
rule-out rabies
CDC Points of Contact Rabies Duty Officers
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.3 Page 295 of 363


Test Order
Rabies Confirmatory Testing (Human)
CDC-10395

Synonym(s) None
Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/rabies/pdf/rorform.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen All four of the following are required for antemortem testing: serum, CSF, Nuchal
Type for Testing (skin) biopsy, and saliva. Fresh-frozen brain tissues for postmortem testing: full
cross section of brain stem and cerebellum (vermis right and left lateral lobes).
Minimum Volume Required 500 uL (serum, CSF, saliva)

Storage & Preservation of Keep all samples stored at -80C and ship on dry ice. Serum and CSF can be
Specimen Prior to Shipping refrigerated before shipping. Please see the supplemental link for specific
specimen storage and preservation.
Transport Medium Saliva and nuchal (skin) biopsy should not be put in a transport medium
Specimen Labeling Two patient identifiers on the specimen container and the test requisition,
sample type and date of collection
Shipping Instructions which Ship all specimens overnight, first AM delivery and provide the CDC Point of
Include Specimen Handling Contact with the tracking number of package.
Requirements
Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology IgG by IFA (Serum and CSF), DFA (Nuchal (skin) biopsy and for rabies virus
antigen), Antigenic Typing (brain), RT-PCR, Sequence Analysis, Isolation, Direct
Rapid Immunohistochemistry test (DRIT), IHC, Viral Neutralizing Antibodies by
RFFIT (Serum and CSF)
Turnaround Time 3 Days
Interferences & Limitations Saliva and CSF specimen should be free of blood because blood may interfere
with test results due to the inhibitors present in blood. Test is limited by
decomposed tissues due to denaturation of viral proteins.
Additional lnformation Sequencing will only be performed if the RT-PCR test is positive. Nuchal (skin)
biopsy has to be a full punch (5-6 millimeters). If testing needs to be repeated
results may take up to 7 days.
CDC Points of Contact Rabies Duty Officer
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.1 Page 296 of 363


Test Order
Rabies Postmortem Human Testing
CDC-10396

Synonym(s) Rabies DFA


Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/rabies/pdf/rorform.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Fresh-frozen brain tissues: full cross section of brain stem and cerebellum
Type for Testing (vermis, right and left lateral lobes). Other specimens may be submitted upon
consultation with Rabies Duty Officer.
Minimum Volume Required Not Applicable

Storage & Preservation of Stored at -80C and should be kept on dry ice
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Two patient identifiers on the specimen container and the test requisition,
sample type and date of collection
Shipping Instructions which Ship all specimens overnight, first AM delivery and provide the CDC Point of
Include Specimen Handling Contact with the tracking number of package
Requirements
Frozen specimen should be shipped on dry ice
Methodology DFA for rabies virus antigen, RT-PCR, Direct Rapid Immunohistochemistry test
(DRIT), Virus Isolation, Sequence Analysis, Antigenic Typing
Turnaround Time 7 Days
Interferences & Limitations Tests are limited by decomposed tissues due to denaturation of viral proteins
Additional lnformation Turnaround time for results from fresh frozen tissue is shorter than from
formalin-fixed tissues. Tissues submitted in formalin require additional
processing.
CDC Points of Contact Rabies Duty Officer
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.1 Page 297 of 363


Test Order
Rabies Special Study
CDC-10501

Synonym(s) None
Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Singletary-Meadows, Kristi, (404) 639-2833, kts9@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/rabies/pdf/rorform.pdf
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required

Storage & Preservation of Stored at -80C and should be kept on dry ice.
Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Kristi Singletary-Meadows
(404) 639-2833
kts9@cdc.gov
Subbian Satheshkumar Panayampalli
(404) 639-1594
xdv3@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 298 of 363


Test Order
Rabies Virus Genetic Typing
CDC-10397

Synonym(s) Rabies Antigenic Typing, Rabies Monoclonal Antibody Typing, Rabies MAB
Typing, Rabies RT-PCR, Rabies Sequence Analysis, Rabies Variant Typing
Pre-Approval Needed Rabies Duty Officer, , (404) 639-1050,
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/rabies/pdf/rorform.pdf
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Fresh-frozen brain tissues: full cross section of brain stem and cerebellum
Type for Testing (vermis, right and left lateral lobes) preferred, or a viral isolate. Other specimens
may be submitted upon consultation with Rabies Duty Officer.
Minimum Volume Required Not Applicable

Storage & Preservation of Stored at -80C and should be kept on dry ice
Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Two unique identifiers for human specimen and one unique identifier for animal
specimen, date of collection and specimen type
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries and provide the
Include Specimen Handling CDC Point of Contact with the tracking number of package
Requirements
Frozen specimen should be shipped on dry ice
Methodology DFA, IFA, Sequence Analysis, RT-PCR, Isolation
Turnaround Time 7 Days
Interferences & Limitations Tests are limited by decomposed tissues due to denaturation of viral proteins
Additional lnformation Urgent specimens will be reported within 24 hours if the test does not need to
be repeated. Non-urgent specimen may take longer than 7 days.
CDC Points of Contact Rabies Duty Officer
(404) 639-1050

Tuesday, November 29, 2016 Version: 1.1 Page 299 of 363


Test Order
Respiratory Agents (Chlamydia, Legionella, Mycoplasma)
Molecular Detection
CDC-10157
Synonym(s) Atypical pneumonia, CAP, Chlamydia pneumoniae, Legionnaires' disease or LD,
Legionellosis, Pontiac fever, Walking pneumonia
Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal (NP) and/or Oropharyngeal (OP) swabs, and any lower
Type for Testing respiratory tract specimen including bronchoalveolar lavage (BAL) and sputum.
Others upon consultation with laboratory.
Minimum Volume Required 1 mL

Storage & Preservation of Specimens can be kept refrigerated if shipped in less than 72 hours of collection;
Specimen Prior to Shipping otherwise specimen should be kept frozen. Store swabs in universal transport
medium.
Transport Medium Universal transport medium
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be sent on ice packs
Frozen specimen should be sent on dry ice
Methodology Real Time PCR
Turnaround Time 7 Days
Interferences & Limitations Do not use cotton swabs with wooden shafts. Specimen should be acquired prior
to antibiotic treatment. Improper specimen storage and handling may result in
inconclusive or inaccurate results.
Additional lnformation None
CDC Points of Contact Jonas Winchell
(404) 639-4921
Jwinchell@cdc.gov
Maureen Diaz
(404) 639-4534
mdiaz1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 300 of 363


Test Order
Respiratory Virus (Not Influenza) Special Study
CDC-10400

Synonym(s) None
Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 301 of 363


Test Order
Respiratory Virus Molecular Detection (Not Influenza)
CDC-10401

Synonym(s) Non-influenza Respiratory Virus


Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Upper or lower respiratory tract specimens; pure culture isolate
Type for Testing
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate all specimens promptly after collection. If specimens can be shipped
Specimen Prior to Shipping to CDC within 72 hours of collection, they should be kept refrigerated at 4C and
shipped on gel ice-packs. Freezing should be avoided if possible, as this will
reduce virus infectivity. Specimens for virus culture should not be frozen at -20
C. If specimens must be held for >72 hours, they should be promptly frozen
at -70C and shipped on dry ice. Liquid specimens should be aliquoted into
properly labeled, leak-proof, unbreakable screw cap vials. Samples should be
collected and processed in a manner that prevents cross-contamination between
specimens, including changing gloves between specimens.
Transport Medium Swabs may be shipped in commercial viral transport media
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 3 Weeks
Interferences & Limitations Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays.
Additional lnformation None
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 302 of 363


Test Order
Rickettsia Molecular Detection
CDC-10402

Synonym(s) Rickettsiosis, Rocky Mountain Spotted Fever (RMSF), Spotted fever group
Rickettsia (SFG), Typhus group Rickettsia (TG)
Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Acute samples only, anticoagulated whole blood collected in:
Type for Testing Ethylenediaminetetraacetic acid (EDTA), Anticoagulant Citrate Dextrose Solution
A (ACD-A), Sodium Citrate, or Heparin treated tubes are acceptable; serum; fresh
tissue biopsy
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium For blood; Ethylenediaminetetraacetic acid (EDTA), Anticoagulant Citrate


Dextrose Solution A (ACD-A), Sodium Citrate, or Heparin blood tubes for blood;
for tissue in a sample collection tube - please request guidance
Specimen Labeling Patient name, date of birth, and date of collection
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Real Time Polymerase chain Reaction (PCR), Polymerase Chain Reaction (PCR),
Sequencing
Turnaround Time 6 Weeks
Interferences & Limitations Hemolysis in whole blood specimen will interfere with results. Multiple freeze
thaw cycles and sample storage above refrigerated temperatures will interfere
with proper nucleic acid extraction. If a specimen is drawn at convalescence it
will reduce the chance of the target organism being present in blood. Avoid
collection of blood specimen in heparin tubes.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-0152
ckato@cdc.gov
Ida Chung
(404) 639-0500
ipi8@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 303 of 363


Test Order
Rickettsia Serology Spotted Fever Group (RMSF) Serology
CDC-10403

Synonym(s) Spotted fever group Rickettsiosis, Rocky Mountain Spotted Fever (RMSF)
Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology IFA (Immunofluorescence Assay)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact lab prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 2.3 Page 304 of 363


Test Order
Rickettsia Serology Typhus Group Serology
CDC-10404

Synonym(s) Typhus Group Rickettsiosis, Including epidemic Typhus and murine Typhus
Pre-Approval Needed None
Supplemental Information Prior approval is required if the following information is not provided:
Required - Suspected Agent
- Travel and exposure history (including animals, arthropods, etc.)
- Date of illness onset (and time if available)
- Specimen type (e.g., serum, whole blood, tissue, etc.)
- Test requested
- Brief clinical summary (including details of antibiotic therapy and dates) and
pertinent clinical findings
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing -acute (during active stage of illness)
-convalescent (2-4 weeks after acute stage)
Minimum Volume Required 1.0 mL

Storage & Preservation of Ideally keep specimen at a refrigerated temperature not frozen. If previously
Specimen Prior to Shipping frozen, then keep specimen frozen.

Transport Medium Not Applicable


Specimen Labeling Patient name and date of birth
Shipping Instructions which Ship Monday - Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped refrigerated on cold packs.
Requirements
Methodology Indirect Fluorescence Assay (IFA)
Turnaround Time 6 Weeks
Interferences & Limitations Multiple freeze thaw cycles may interfere with antigen binding. Use sterile
technique to avoid contamination of sample as this may compromise the sample
and interfere with the ability to get accurate results. Acute and convalescent
serum is needed for accurate diagnosis and if unable to collect both please
contact laboratory prior to shipping.
Additional lnformation The Rickettsial Zoonoses Branch Reference Diagnostic Laboratory aids State
Laboratories in diagnosis of difficult samples/cases or if specialized tests are
needed. Routine diagnostic samples should be sent to your State Laboratory or a
commercial laboratory.
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 305 of 363


Test Order
Rickettsia Special Study
CDC-10405

Synonym(s) Rickettsiosis, Rocky Mountain Spotted Fever (RMSF), Spotted fever group
Rickettsia (SFG), Typhus group Rickettsia (TG)
Pre-Approval Needed Kato, Cecilia, (404) 639-1075, ckato@cdc.gov
Paddock, Christopher, (404) 639-1309, cdp9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Molecular detection, Serology, Culture, Immunohistochemistry (IHC), Other
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cecilia Kato
(404) 639-1075
ckato@cdc.gov
Christopher Paddock
(404) 639-1309
cdp9@cdc.gov

Tuesday, November 29, 2016 Version: 1.4 Page 306 of 363


Test Order
Rift Valley Fever (RVF) Identification
CDC-10406

Synonym(s) RVF
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 307 of 363


Test Order
Rift Valley Fever (RVF) Serology
CDC-10407

Synonym(s) RVF
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 308 of 363


Test Order
Rotavirus Detection
CDC-10408

Synonym(s) Rotavirus Antigen EIA, Rotavirus Antigen ELISA, Rotavirus RT-PCR


Pre-Approval Needed None
Supplemental Information Contact laboratory for supplemental forms
Required
Supplemental Form None
Performed on Specimens From None

Acceptable Sample/ Specimen Human stool


Type for Testing
Minimum Volume Required 0.25 g or 0.25 mL

Storage & Preservation of Specimen should be kept either frozen at -20C or colder or refrigerated at 4C.
Specimen Prior to Shipping Specimen tubes or cups must be packed inside of a leak proof secondary
container. The secondary container needs to be packed inside an approved class
B specimen shipping container (i.e. Fisher scientific cat# 22-130-431).
Transport Medium Do not send specimen in bacterial or viral transport medium or a fixative
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Wednesday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs

Include a hardcopy list of specimens with your shipment. Please notify Mike
Bowen (mkb6@cdc.gov) and Charity Perkins (vmf4@cdc.gov) when you are going
to send specimens, and include the shipment tracking number if possible.
Methodology Enzyme immunoassay (EIA), RT-PCR
Turnaround Time 14 Days
Interferences & Limitations None
Additional lnformation Contact laboratory for instructions to recover a limited sample from diaper
material
CDC Points of Contact Mike Bowen
(404) 639-4922
mkb6@cdc.gov
Charity Perkins
(404) 639-0885
vmf4@cdc.gov

Tuesday, November 29, 2016 Version: 2.1 Page 309 of 363


Test Order
Rotavirus Genotyping
CDC-10409

Synonym(s) Rotavirus Real Time RT-PCR, Rotavirus RT-PCR, Rotavirus Sequencing


Pre-Approval Needed None
Supplemental Information Contact laboratory for supplemental forms.
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Human stool


Type for Testing
Minimum Volume Required 0.25 g or 0.25 mL

Storage & Preservation of Specimen should be kept either frozen at -20C or colder or refrigerated at 4C.
Specimen Prior to Shipping Specimen tubes or cups must be packed inside of a leak proof secondary
container. The secondary container needs to be packed inside an approved class
B specimen shipping container (i.e. Fisher scientific cat# 22-130-431).
Transport Medium Do not send specimen in bacterial or viral transport medium or a fixative
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Wednesday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs

Include a hardcopy list of specimens with your shipment. Please notify Mike
Bowen (mkb6@cdc.gov) and Charity Perkins (vmf4@cdc.gov) when you are going
to send specimens, and include the shipment tracking number if possible.
Methodology RT-PCR, Sequencing
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation Contact laboratory for instructions to recover a limited sample from diaper
material
CDC Points of Contact Mike Bowen
(404) 639-4922
mkb6@cdc.gov
Charity Perkins
(404) 639-0885
vmf4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 310 of 363


Test Order
Rubella Detection (PCR) and Genotyping
CDC-10242

Synonym(s) German measles, three day measles


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Throat swab in viral medium, nasopharyngeal aspirate or swab, Urine, cataracts,
Type for Testing lens aspirate, oral fluid, cerebrospinal fluid (CSF), dry blood spots, and tissue
samples
Minimum Volume Required Not Applicable

Storage & Preservation of See: http://www.cdc.gov/rubella/lab/lab-specimens.html for collection and


Specimen Prior to Shipping storage protocol

Transport Medium Viral transport medium for swabs and appropriate culture medium. Make sure
tubes are all in leak proof containers.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which The laboratory requests that the sender contacts the laboratory by email or
Include Specimen Handling phone before shipping
Requirements
Ship specimen Monday -Thursday overnight to avoid weekend deliveries

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on cold packs
Methodology Template production by RT-PCR, Real time RT-PCR, Viral culture, Genotyping by
Nucleic acid sequencing
Turnaround Time 7 Days
Interferences & Limitations See: http://www.cdc.gov/rubella/lab/index.html for information on the
interferences and limitiations
Additional lnformation Please include vaccination history, age, date of onset and sample collection.

For additional information please refer to:


http://www.cdc.gov/vaccines/pubs/surv-manual/index.html and
http://www.cdc.gov/measles/lab-tools/index.html
CDC Points of Contact Joe Icenogle
(404) 639-4557
jci1@cdc.gov
Emily Abernathy
(404) 639-1249
efa9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 311 of 363


Test Order
Rubella Serology
CDC-10246

Synonym(s) German measles, three day measles


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and others upon consultation


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Serum should be kept refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated or frozen specimen should be shipped on cold packs
Laboratory will instruct on how to ship for other specimen types
Methodology Commercial capture IgM, Commercial indirect IgG
Turnaround Time 7 Days
Interferences & Limitations IgM positive may not occur until 5 days post-rash onset
Additional lnformation IgM and IgG assays are qualitative assays
For outbreaks or immuno-compromised patients please contact laboratory prior
to shipment
CDC Points of Contact Joe Icenogle
(404) 639-4557
jci1@cdc.gov
Emily Abernathy
(404) 639-1249
efa9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 312 of 363


Test Order
Rubella Serology (IgM and IgG) and Avidity
CDC-10249

Synonym(s) German measles, three day measles


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Serum should be kept refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Clearly label specimen type.


Shipping Instructions which The laboratory requests that the sender contacts the laboratory by email or
Include Specimen Handling phone before shipping
Requirements
Ship specimen Monday -Thursday overnight to avoid weekend deliveries

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on cold packs
Methodology CDC IgG avidity assay
Turnaround Time 7 Days
Interferences & Limitations Date of onset is necessary for accurate interpretation
Additional lnformation Date of onset, vaccination status, age, date of collection and pregnancy status if
applicable.
CDC Points of Contact Joe Icenogle
(404) 639-4557
jci1@cdc.gov
Emily Abernathy
(404) 639-1249
efa9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 313 of 363


Test Order
Rubella Special Study
CDC-10253

Synonym(s) German measles, three day measles


Pre-Approval Needed Icenogle, Joe, (404) 639-4557, jci1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Joe Icenogle
(404) 639-4557
jci1@cdc.gov
Emily Abernathy
(404) 639-1249
efa9@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 314 of 363


Test Order
Salmonella Identification and Serotyping
CDC-10110

Synonym(s) Salmonella Typing


Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens; Please call for approval
Required prior to sending, other specimen types. Provide any preliminary results
available.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology Phenotypic identification, Phenotypic serotyping, Genetic identification, Genetic
serotyping
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Susan Van Duyne
(404) 639-0186
Mdv9@cdc.gov
Patricia Fields
(404) 639-1748
pif1@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 315 of 363


Test Order
Salmonella serovar Typhi (only) serology
CDC-10453

Synonym(s) Enteric Pathogen


Pre-Approval Needed Aubert, Rachael, (404) 639-3816, vrl7@cdc.gov
Korth, Michael, (404) 639-2099, mqk8@cdc.gov
Supplemental Information Date of illness onset, date of serum collection, clinical diagnosis. Indicate if
Required patient is currently on antibiotics. Indicate if patient is suspect chronic carrier.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, paired serum preferred. Do not pool specimens.
Type for Testing
Minimum Volume Required 200 uL (More preferred)

Storage & Preservation of Maintain serum at 4C (preferred); frozen specimens acceptable


Specimen Prior to Shipping

Transport Medium Separate serum from the clot and ship in a sterile labeled tube with the top
tightly closed
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Rachael Aubert (vrl7@cdc.gov, (404) 639-3816) once specimens have been
Requirements shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology Various methods utilized; Consultation required
Turnaround Time 3 Months
Interferences & Limitations Plasma is not acceptable for typhoid testing
Additional lnformation Paired serum specimens always preferred.

Please send one tube per specimen submission form. Submit multiple forms if
needed.
CDC Points of Contact Rachael Aubert
(404) 639-3816
vrl7@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 316 of 363


Test Order
Salmonella Study
CDC-10109

Synonym(s) None
Pre-Approval Needed Van Duyne, Susan, (404) 639-0186, mdv9@cdc.gov
Fields, Patricia, (404) 639-1748, pif1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Susan Van Duyne
(404) 639-0186
Mdv9@cdc.gov
Patricia Fields
(404) 639-1748
Pif1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 317 of 363


Test Order
Salmonella Subtyping
CDC-10108

Synonym(s) Salmonella Typing


Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimen, but is required for all other
Required types of specimen.

Indicate subtyping method(s) requested; provide PulseNet cluster code and


PFGE pattern numbers if appropriate.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Not Applicable
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology Serotyping, PFGE, MLVA, AST
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form. Epidemiologic metadata, PulseNet cluster code, and PFGE pattern
designation requested if available.

Turn around time depends on the nature of subtyping performed; and, results
are typically not reported directly back to the submitter, but deposited in
surveillance databases. If the surveillance database is not accessible to
submitters, results are posted on the PulseNet and OutbreakNet discussion
board. Specific turn around time and a report are available upon request.
CDC Points of Contact Susan Van Duyne
(404) 639-0186
Mdv9@cdc.gov
Patricia Fields
(404) 639-1748
Pif1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 318 of 363


Test Order
SARS Molecular Detection
CDC-10412

Synonym(s) SARS coronavirus


Pre-Approval Needed Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Nasopharyngeal wash/aspirates, nasopharyngeal swabs, oropharyngeal swabs,


Type for Testing broncheoalveolar lavage, tracheal aspirate, pleural fluid tap, sputum, and post-
mortem tissue.
For more information go to http://www.cdc.gov/sars/guidance/F-lab/app4.html
Minimum Volume Required 0.25 mL

Storage & Preservation of Refrigerate or freeze tubes after specimens are placed in them. If specimens will
Specimen Prior to Shipping be examined within 48 hours after collection, they can be refrigerated. If
specimens must be held longer than 48 hours, freeze them as soon as possible
after collection. Although storage in an ultra-low freezer (-70C) is preferable,
storage in a home-type freezer (if properly set at -20C) is acceptable for short
periods.
For more information go to http://www.cdc.gov/sars/guidance/F-lab/app4.html
Transport Medium Swabs may be shipped in commercial viral transport media
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements http://www.cdc.gov/sars/lab/specimen.html
Methodology Polymerase Chain Reaction (PCR), Sequencing
Turnaround Time 3 Days
Interferences & Limitations Use only sterile Dacron or rayon swabs with plastic shafts or if available, flocked
swabs. Do NOT use calcium alginate swabs or swabs with wooden sticks, as they
may contain substances that inactivate some viruses and inhibit some molecular
assays.
Additional lnformation http://www.cdc.gov/sars/about/index.html
http://www.cdc.gov/sars/guidance/F-lab/app5.html
CDC Points of Contact Dean Erdman
(404) 639-3727
dde1@cdc.gov
Shifaq Kamili
(404) 639-2799
sgk5@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 319 of 363


Test Order
SARS Serology
CDC-10413

Synonym(s) SARS-CoV, SARS-CoV EIA, SARS-CoV ELISA, SARS ELISA, SARS EIA
Pre-Approval Needed Haynes, Lia, (404) 639-4004, loh5@cdc.gov
Erdman, Dean, (404) 639-3727, dde1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum (acute and convalescent) and plasma


Type for Testing For more information go to http://www.cdc.gov/sars/guidance/F-lab/app4.html
Minimum Volume Required 200 uL

Storage & Preservation of Collect whole blood in a serum separator tube. Allow the blood to clot,
Specimen Prior to Shipping centrifuge briefly, and collect all the resulting sera in vials with external caps and
internal O-ring seals. If there is no O-ring seal, then seal tightly with the
available cap and secure with Parafilm. Collect whole blood in either EDTA tubes
or in a clotting tube. For plasma, collect blood in EDTA tubes and place in vials
with external caps and internal O-ring seals. Store plasma and serum at 4C.
Serum may be frozen.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Refrigerated specimen should be shipped on cold packs
Frozen specimen should be shipped on dry ice

http://www.cdc.gov/sars/lab/specimen.html
Methodology ELISA
Turnaround Time 3 Days
Interferences & Limitations Do not collect in heparin tubes
Additional lnformation None
CDC Points of Contact Lia Haynes
(404) 639-4004
loh5@cdc.gov
Dean Erdman
(404) 639-3727
dde1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 320 of 363


Test Order
Schistosomiasis Serology
CDC-10466

Synonym(s) Schistosoma mansoni, Schistosoma haematobium, Schistosoma japonicum;


Bilharzia, parasite
Pre-Approval Needed None
Supplemental Information Travel history REQUIRED, include other relevant risk factors; clinical symptoms,
Required treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum and Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology FAST-ELISA, Immunoblot, Western Blot, MAMA, HAMA, JAMA, Antibody Detection
Turnaround Time 21 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 321 of 363


Test Order
Seoul Virus Serology
CDC-10414

Synonym(s) Hanta, HFRS, HPS


Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 322 of 363


Test Order
Shiga Toxin-producing E. coli Isolation from Enrichment Broth
CDC-10105

Synonym(s) STEC, E. coli O157


Pre-Approval Needed None
Supplemental Information Only Stx+ broths that produce growth on subculture should be submitted.
Required Consult with EDLB contact before sending other specimens. Provide any
preliminary results available.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Submit only broths that are positive for Shiga toxins (Stx1/Stx2) or the genes
Type for Testing encoding these toxins and produce growth on subculture. Consult with Dr.
Nancy Strockbine before sending other specimen types or fecal specimens in
enrichment broth that are Stx+/stx+ but no growth of STEC on subculture.
Minimum Volume Required 5 mL (broth)

Storage & Preservation of Maintain specimen at 4C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship with cold packs in compliance with federal and local guidelines. Shiga
toxin-positive broths should be shipped as Category A Infectious Substances.
Methodology Isolation, Phenotypic Identification Including Serotyping, PCR Testing for
Virulence Markers
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation A final report for CDC-10105 will be issued for broths that are not confirmed as
positive by PCR for STEC or from broths that are confirmed as positive by PCR
but from which an STEC isolate can not be obtained. Broths from which an STEC
is isolated will be reflexively assigned test CDC-10114 Escherichia and Shigella
identification, serotyping, and virulence profiling, and a final report will be
issued when results for CDC-10114 are complete. Consult with Dr. Nancy
Strockbine if a preliminary report for CDC-10105 is needed.
CDC Points of Contact Nancy Strockbine Devon Stripling
(404) 639-4186 (404) 639-2251
nas6@cdc.gov euo4@cdc.gov
Nancy Garrett
(404) 639-1964
dgi3@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 323 of 363


Test Order
Special Bacterial Pathogen Study
CDC-10147

Synonym(s) None
Pre-Approval Needed McQuiston, John, (404) 639-0270, zje8@cdc.gov
Whitney, Anne, (404) 639-1374, amw0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact John McQuiston
(404) 639-0270
zje8@cdc.gov
Anne Whitney
(404) 639-1374
amw0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 324 of 363


Test Order
Staphylococcal Toxic Shock Syndrome Toxin (TSST- )
CDC-10426

Synonym(s) Staph Toxin, Toxic Shock Syndrome


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on suitable agar medium


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Isolate should be stored at room temperature


Specimen Prior to Shipping

Transport Medium Pure culture isolate on suitable agar medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries at room
Include Specimen Handling temperature as an etiologic agent.
Requirements
Methodology 16S sequencing, MALDI-TOF, Phenotypic Testing, SEA - SHE, PVL
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation SEA-SHE and PVL testing performed only with prior approval
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Kamile Rasheed
(404) 639-3247
jkr1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 325 of 363


Test Order
Staphylococcus - Micrococcus Identification
CDC-10226

Synonym(s) Staph, Micrococcus, Kocuria Identification


Pre-Approval Needed None
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on suitable agar medium


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Isolate should be stored at room temperature


Specimen Prior to Shipping

Transport Medium Pure culture isolate on suitable agar medium


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries at room
Include Specimen Handling temperature as an etiologic agent.
Requirements
Methodology 16S Sequencing, MALDI-TOF, Phenotypic Testing
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact David Lonsway
(404) 639-2825
Dlonsway@cdc.gov
Valerie Albrecht
(404) 639-4552
gpy8@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 326 of 363


Test Order
Staphylococcus and MRSA Outbreak Strain Typing
CDC-10230

Synonym(s) Staph Typing, MRSA Typing, Staphylococcal Typing


Pre-Approval Needed Rasheed, Kamile, (404) 639-3247, JRasheed@cdc.gov
Albrecht, Valerie, (404) 639-4552, gpy8@cdc.gov
Supplemental Information Prior approval and Epidemiologic consultation required
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on suitable agar medium. Additional specimen types upon
Type for Testing consultation with laboratory.
Minimum Volume Required Not Applicable

Storage & Preservation of Isolate should be stored at room temperature


Specimen Prior to Shipping

Transport Medium Pure culture isolate on suitable agar medium or frozen in TSB plus glycerol
Specimen Labeling Include date of isolation and unique specimen identifier
Shipping Instructions which Ship specimen Monday -Thursday overnight to avoid weekend deliveries at room
Include Specimen Handling temperature as an etiologic agent.
Requirements
Methodology 16S Sequencing, MALDI-TOF, Phenotypic Testing, Molecular Strain Typing
Turnaround Time 28 Days
Interferences & Limitations None
Additional lnformation Not CLIA compliant testing; for epidemiologic purposes only
CDC Points of Contact Kamile Rasheed
(404) 639-3247
JRasheed@cdc.gov
Valerie Albrecht
(404) 639-4552
gpy8@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 327 of 363


Test Order
Staphylococcus aureus Detection - Foodborne Outbreak
CDC-10113

Synonym(s) None
Pre-Approval Needed Luquez, Carolina, (404) 639-0896, fry6@cdc.gov
Gomez, Gerry, (404) 639-0537, goe4@cdc.gov
Supplemental Information Only specimens from foodborne outbreaks accepted. Consult with EDLB
Required contact before sending specimens. Provide any preliminary results if available.
Supplemental Form None
Performed on Specimens From Human and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates, vomitus, stool, food. Only specimens from foodborne outbreaks
Type for Testing accepted. Consult with Carolina Luquez and Gerry Gomez before sending
specimens.
Minimum Volume Required 25 g (food), 10 g (vomitus, stool)

Storage & Preservation of Maintain food, vomitus and stool at 4C


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Carolina Luquez (fry6@cdc.gov) and Gerry Gomez (goe4@cdc.gov) once
Requirements specimens have been shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology Toxin Detection in Food, Culture, PCR
Turnaround Time 2 Months
Interferences & Limitations None
Additional lnformation Direct toxin detection requires food samples
CDC Points of Contact Carolina Luquez
(404) 639-0896
fyr6@cdc.gov
Gerry Gomez
(404) 639-0537
goe4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 328 of 363


Test Order
STD Bacterial Molecular Diagnostic Evaluation
CDC-10178

Synonym(s) Sexually Transmitted Disease


Pre-Approval Needed Trees, David, (404) 639-2134, dlt1@cdc.gov
Johnson, Steve, (404) 639-2879, sbj1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Gonococcal bacterial culture


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Store culture at -70C in TSA with 20% glycerol medium
Specimen Prior to Shipping

Transport Medium TSA with 20% glycerol


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped on dry ice, as an etiologic agent.
Requirements
Methodology Molecular cloning, PCR, Whole genome sequencing
Turnaround Time 12 Weeks
Interferences & Limitations None
Additional lnformation Please provide information on any antibiotics the patient may have been treated
with
CDC Points of Contact David Trees
(404) 639-2134
dlt1@cdc.gov
Steve Johnson
(404) 639-2879
sbj1@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 329 of 363


Test Order
STD International QA - N. gonorrhoeae, C. trachomatis, M.
genitalium, T. vaginalis
CDC-10175
Synonym(s) Sexually Transmitted Disease
Pre-Approval Needed Cheng, Cheng, (404) 639-3154, cyc1@cdc.gov
Chi, Kai, (404) 639-0694, krc2@cdc.gov
Supplemental Information Determined upon consultation
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Urine, oral pharynx swabs, cervical swabs, vaginal swabs, and rectal swabs
Type for Testing collected on any commercially available product, and other specimen types upon
consultation with laboratory
Minimum Volume Required Not Applicable

Storage & Preservation of Swabs must be kept frozen


Specimen Prior to Shipping

Transport Medium Should be transported on commercial Nucleic Acid Amplification Test (NAAT)
medium
Specimen Labeling Please include country of origin, de-linked identifier and date of collection
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Specimen
Include Specimen Handling should be shipped on dry ice, as an etiologic agent.
Requirements
Methodology PCR
Turnaround Time 12 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Cheng Chen
(404) 639-3154
cyc1@cdc.gov
Kai Chi
(404) 639-0694
krc2@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 330 of 363


Test Order
Strep ABCs Surveillance Study
CDC-10218

Synonym(s) None
Pre-Approval Needed McGee, Lesley, (404) 639-0455, afi4@cdc.gov
Beall, Bernard, (404) 639-1237, bbeall@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/abcs/downloads/ABCs-case-rpt-form.pdf
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Sterile site Isolates of GAS, GBS and S.pneumoniae that meet the ABCs inclusion
Type for Testing criteria
Minimum Volume Required Not applicable

Storage & Preservation of For isolates, store on blood or chocolate agar, in transport media or as a frozen
Specimen Prior to Shipping glycerol stock; additional details and directions will be provided upon
consultation.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 8 Weeks
Interferences & Limitations Based on consultation
Additional lnformation None
CDC Points of Contact Lesley McGee
(404) 639-0455
afi4@cdc.gov
Bernard Beall
(404) 639-1237
bbeall@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 331 of 363


Test Order
Streptococcus (Beta Hemolytic Strep) Typing
CDC-10216

Synonym(s) GAS typing, GBS typing, other beta hemolytic strep, Group A Strep, Group B Strep
Pre-Approval Needed Beall, Bernard, (404) 639-1237, bbeall@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/streplab/other-streptococci-qa.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates and clinical/environmental specimens and others as approved upon
Type for Testing consultation
Minimum Volume Required Not Applicable

Storage & Preservation of For isolates, store on blood or chocolate agar, in transport media or as a frozen
Specimen Prior to Shipping glycerol stock; additional details and directions will be provided upon
consultation.
Transport Medium Dependent on specimen type to be determined upon consultation
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 2 Weeks
Interferences & Limitations Based on consultation
Additional lnformation Please complete questionnaire on website
CDC Points of Contact Bernard Beall
(404) 639-1237
bbeall@cdc.gov
Patricia Shewmaker
(404) 639-4826
paw3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 332 of 363


Test Order
Streptococcus (Catalase negative, Gram Positive Coccus)
Identification
CDC-10213
Synonym(s) Streptococci, enterococci, viridans streptococci
Pre-Approval Needed Beall, Bernard, (404) 639-1237, bbeall@cdc.gov
Shewmaker, Patricia, (404) 639-4826, paw3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/streplab/other-streptococci-qa.html
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates and clinical/environmental specimens and others as approved upon
Type for Testing consultation
Minimum Volume Required Not Applicable

Storage & Preservation of For isolates, store on blood or chocolate agar, in transport media or as a frozen
Specimen Prior to Shipping glycerol stock; additional details and directions will be provided upon
consultation.
Transport Medium Dependent on specimen type to be determined upon consultation
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 8 Weeks
Interferences & Limitations Based on consultation
Additional lnformation Please complete questionnaire on website
CDC Points of Contact Bernard Beall
(404) 639-1237
bbeall@cdc.gov
Patricia Shewmaker
(404) 639-4826
paw3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 333 of 363


Test Order
Streptococcus (Catalase negative, Gram Positive Coccus)
Identification and AST
CDC-10214
Synonym(s) Streptococci, enterococci, viridans streptococci
Pre-Approval Needed Beall, Bernard, (404) 639-1237, BBEALL@cdc.gov
Shewmaker, Patricia, (404) 639-4826, paw3@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Pure culture isolate on a suitable agar slant medium; Prior consultation required
Type for Testing for other sample/specimen types
Minimum Volume Required Not applicable

Storage & Preservation of Keep refrigerated if cannot ship immediately


Specimen Prior to Shipping

Transport Medium Suitable agar slant medium (example: blood or chocolate); Frozen glycerol stock
is also acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
At room temperature for any etiologic agents
Methodology Phenotypic Testing, Molecular Testing, Broth microdilution MIC
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Preliminary susceptibility results may be available within 28 days or less.
If susceptibility has been performed, indicate the method and results.
Date of specimen collection and original submitter.
CDC Points of Contact Bernard Beall David Lonsway
(404) 639-1237 (404) 639- 2825
BBEALL@cdc.gov dul7@cdc.gov
Patricia Shewmaker
(404) 639-2825
paw3@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 334 of 363


Test Order
Streptococcus pneumoniae Typing
CDC-10215

Synonym(s) Pneumococcus Serotyping


Pre-Approval Needed Beall, Bernard, (404) 639-1237, bbeall@cdc.gov
Supplemental Information Online form required for pre-approval: http://www.cdc.gov/streplab/s-
Required pneumoniae-qa.html
If you have questions, contact Bernard Beall, bbeall@cdc.gov, 404-639-1237
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates and clinical/environmental specimens and others as approved upon
Type for Testing consultation
Minimum Volume Required Not Applicable

Storage & Preservation of For isolates, store on blood or chocolate agar, in transport media or as a frozen
Specimen Prior to Shipping glycerol stock; additional details and directions will be provided upon
consultation.
Transport Medium Dependent on specimen type to be determined upon consultation
Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition.
Shipping Instructions which Ship specimen Monday -Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Frozen specimen should be shipped on dry ice
Refrigerated specimen should be shipped on cold packs
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 2 Weeks
Interferences & Limitations Based on consultation
Additional lnformation Please complete questionnaire on website
CDC Points of Contact Bernard Beall
(404) 639-1237
bbeall@cdc.gov
Lesley McGee
(404) 639-0455
afi4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 335 of 363


Test Order
Streptococcus Study
CDC-10217

Synonym(s) None
Pre-Approval Needed Beall, Bernard, (404) 639-1237, bbeall@cdc.gov
McGee, Lesley, (404) 639-0455, afi4@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates and clinical/environmental specimens and others as approved upon
Type for Testing consultation
Minimum Volume Required To be determined

Storage & Preservation of For isolates blood or chocolate agar; transport media or frozen glycerol stock;
Specimen Prior to Shipping additional details and directions will be provided upon consultation.

Transport Medium To be determined


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.

Note: surveillance studies may label specimens according to protocol


Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology Phenotypic Testing, Molecular Testing
Turnaround Time 8 Weeks
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Bernard Beall
(404) 639-1237
bbeall@cdc.gov
Lesley McGee
(404) 639-0455
afi4@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 336 of 363


Test Order
Strongyloidiasis Serology
CDC-10467

Synonym(s) Strongyloidiasis, Strongyloides stercoralis, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology EIA, ELISA, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 337 of 363


Test Order
Syphilis Serology
CDC-10173

Synonym(s) Treponemal and non-treponemal


Pre-Approval Needed None
Supplemental Information Need to supply date of birth
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum (preferred), CSF, and/or plasma (possible to preform test but not
Type for Testing preferred)
Minimum Volume Required 1 mL (for serum or plasma)

Storage & Preservation of Serum and Plasma can be stored at 4C unless for more than 4-5 days it should
Specimen Prior to Shipping be frozen. CSF should be stored frozen at -70C.

Transport Medium None


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice and refrigerated specimen should be
Requirements shipped on cold packs, as an etiologic agent.
Methodology RPR, TPPA, TrepSURE, CSF-VDRL
Turnaround Time 2 Weeks
Interferences & Limitations Avoid freeze-thaw cycles as this can affect test results
Additional lnformation None
CDC Points of Contact Yetunde Fakile Yongcheng Sun
(404) 639-3784 (404) 639-2905
yfakile@cdc.gov Yas2@cdc.gov
Andre Hopkins
(404) 639-0731
Fvn4@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 338 of 363


Test Order
Tick Borne Encephalitis (TBE) Identification
CDC-10415

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Frozen tissue, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be placed in plastic screw capped vials, frozen to -70C, and kept
Specimen Prior to Shipping frozen until shipment. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped frozen on dry ice. See supplemental submission forms for further
Requirements details. Do not ship specimen without prior consultation and approval.
Methodology Molecular Typing, Polymerase Chain Reaction (PCR)
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity.
Heparin may cause interference with the molecular tests and should be avoided.
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 339 of 363


Test Order
Tick Borne Encephalitis (TBE) Serology
CDC-10416

Synonym(s) None
Pre-Approval Needed Klena, John, (404) 639-0114, irc4@cdc.gov
Rollin, Pierre, (404) 639-1124, pyr3@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/ncezid/dhcpp/vspb/pdf/specimen-submission.pdf

Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen CSF, blood and serum


Type for Testing
Minimum Volume Required 1 mL

Storage & Preservation of Specimen must be kept cold (at or below 4C). If possible place specimen in
Specimen Prior to Shipping plastic screw capped vials. See link to supplemental submission form for specific
information on various specimen types.
Transport Medium Not Applicable
Specimen Labeling Patient name, patient ID #, specimen type, date collected
Shipping Instructions which Ship Monday-Thursday overnight to avoid weekend deliveries. Specimen should
Include Specimen Handling be shipped on cold packs or dry ice if frozen. See supplemental submission
Requirements forms for further details. Do not ship specimen without prior consultation and
approval.
Methodology ELISA
Turnaround Time 10 Days
Interferences & Limitations Specimen must remain frozen; warming or freeze thawing reduces sensitivity
Additional lnformation Critical specimens will take less than 4 days to turn around. See link to
supplemental submission forms for detailed information.
CDC Points of Contact John Klena
(404) 639-0114
irc4@cdc.gov
Pierre Rollin
(404) 639-1124
pyr3@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 340 of 363


Test Order
Toxocariasis Serology
CDC-10468

Synonym(s) Larva migrans, Toxocariasis, Toxocara canis, Toxocara cati, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors; clinical
Required symptoms, treatment and relevant lab results.
Supplemental Form None
Performed on Specimens From None

Acceptable Sample/ Specimen Serum, plasma, or vitreous fluid


Type for Testing
Minimum Volume Required 0.5

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology EIA, ELISA, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 718-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 4.0 Page 341 of 363


Test Order
Toxoplasmosis Special Study
CDC-10492

Synonym(s) None
Pre-Approval Needed Rivera, Hilda, (404) 718-4100, igi2@cdc.gov
DPDx, , (404) 718-4120, dpdx@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From None

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Hilda Rivera
(404) 718-4100
igi2@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 1.2 Page 342 of 363


Test Order
Treponema pallidum Molecular Detection
CDC-10176

Synonym(s) Syphilis
Pre-Approval Needed Pillay, Allan, (404) 639-2140, apillay@cdc.gov
Chi, Kai, (404) 639-0694, krc2@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Swab of an ulcer or skin lesion, blood collected in an EDTA tube, body fluids,
Type for Testing frozen tissue and/or Formalin-Fixed, Paraffin-Embedded (FFPE) tissue
Minimum Volume Required Not Applicable

Storage & Preservation of Specimens should be frozen unless FFPE tissue which can be stored at room
Specimen Prior to Shipping temperature

Transport Medium Should be transported on commercial Nucleic Acid Amplification Test (NAAT)
medium
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice, refrigerated specimen should be shipped
Requirements on cold packs and FFPE can be shipped at room temperature, as an etiologic
agent.
Methodology PCR
Turnaround Time 2 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Allan Pillay
(404) 639-2140
apillay@cdc.gov
Kai Chi
(404) 639-0694
krc2@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 343 of 363


Test Order
Treponema pallidum Molecular Typing
CDC-10177

Synonym(s) Treponema pallidum Genotyping, Treponema pallidum Strain Typing, Syphilis


Typing
Pre-Approval Needed Pillay, Allan, (404) 639-2140, apillay@cdc.gov
Chen, Cheng, (404) 639-3154, cyc1@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Swab of an ulcer or skin lesion, blood collected in an EDTA tube, body fluids,
Type for Testing frozen tissue and/or Formalin-Fixed, Paraffin-Embedded (FFPE) tissue
Minimum Volume Required Not Applicable

Storage & Preservation of Specimens should be frozen except for FFPE tissue, which can be stored at room
Specimen Prior to Shipping temperature

Transport Medium Should be transported on commercial Nucleic Acid Amplification Test (NAAT)
medium
Specimen Labeling Test subject to CLIA regulations require two patient identifiers on the specimen
container and the test requisition. Also, include date collected.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Frozen
Include Specimen Handling specimen should be shipped on dry ice, refrigerated specimen should be shipped
Requirements on cold packs and FFPE can be shipped at room temperature, as an etiologic
agent.
Methodology PCR, Sequencing, RFLP
Turnaround Time 4 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Allan Pillay
(404) 639-2140
apillay@cdc.gov
Cheng Chen
(404) 639-3154
cyc1@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 344 of 363


Test Order
Trichinellosis Serology
CDC-10470

Synonym(s) Trichinosis,Trichinella spiralis, parasite


Pre-Approval Needed None
Supplemental Information Exposure and travel history, include other relevant risk factors (consumption of
Required raw or undercooked pork or game meat); clinical symptoms, treatment and
relevant lab results.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or Plasma


Type for Testing
Minimum Volume Required 0.5 mL

Storage & Preservation of No specific requirements


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday Thursday, overnight to avoid weekend deliveries. Ship specimen
Include Specimen Handling at room temperature, not on dry ice, as an etiologic agent.
Requirements
Methodology EIA, ELISA, Antibody Detection
Turnaround Time 18 Days
Interferences & Limitations Substances known to interfere with immunoassays include: bilirubin, lipids, and
hemoglobin
Additional lnformation None
CDC Points of Contact Isabel McAuliffe
(404) 719-4100
ibm4@cdc.gov
DPDx
(404) 718-4120
dpdx@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 345 of 363


Test Order
Trichomonas Susceptibility
CDC-10239

Synonym(s) Trichomonas, trich, parasite


Pre-Approval Needed None
Supplemental Information Please fill out the supplemental form provided in the specimen collection kit.
Required Please call 404-718-4141 or 404-718-4142 to request a kit with media and
forms. Alternatively, send mailing address and phone number to was4
@cdc.gov to request a kit.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Must be a live culture. Use vaginal swab to inoculate media.
Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of Do not freeze specimen. If the specimen cannot be sent within 24-48 hours of
Specimen Prior to Shipping collection, it is better to wait to collect the specimen.

Transport Medium InPouch TV (Commercial product) or Diamonds TYM


Please call 404-718-4141 or 404-718-4142 to request a kit with media and
forms. Alternatively, send mailing address and phone number to was4@cdc.gov
to request a kit.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which The isolate should be sent to CDC by overnight courier (not USPS) on the same
Include Specimen Handling day it is obtained from the patient.
Requirements
Insure the InPouch is properly closed and place it in the mailing container that
they arrived in and send by OVERNIGHT delivery service (recommended: Federal
Express) to:

Pete Augostini
CDC/Parasitic Disease Branch
1600 Clifton Rd. NE, MS D65
Bldg. 23, 10th Floor, Rm. 108
Atlanta, GA 30329-4081
678-860-6128

NOTE:
a) Delivery to the reference laboratory within 24 hours is essential to ensure
organism survival.
B) The laboratory can only accept sample delivery Monday through Friday. Please
plan to ship your samples Monday, Tuesday, Wednesday, or Thursday in order
for the laboratory to receive the overnight delivery the next day.
C) While we provide the testing as a no-cost service, we do not have the funds to
pay for shipment of the organism. Therefore, please do not mark recipient as
the party responsible for payment of shipment costs. If this occurs, we will refer
the shipping company back to you for payment of costs.
Please include the metronidazole treatment history and request forms with your
sample.
Methodology Antimicrobial susceptibility
Turnaround Time 7 Weeks

Tuesday, November 29, 2016 Version: 2.2 Page 346 of 363


Test Order
Trichomonas Susceptibility
CDC-10239

Interferences & Limitations None


Additional lnformation None
CDC Points of Contact Evan Secor
(404) 718-4141
was4@cdc.gov

Tuesday, November 29, 2016 Version: 2.2 Page 347 of 363


Test Order
Trypanosoma cruzi Molecular Detection
CDC-10493

Synonym(s) Chagas, American Trypanosomiasis, parasite, triatomine, kissing bug


Pre-Approval Needed None
Supplemental Information Please include detailed information where the insect was found (kitchen, bed,
Required porch, etc.).
Supplemental Form None
Performed on Specimens From Animal

Acceptable Sample/ Specimen Triatomine insect


Type for Testing
Minimum Volume Required N/A

Storage & Preservation of Dry or in 70% ethanol


Specimen Prior to Shipping

Transport Medium None or in 70% ethanol


Specimen Labeling One submitter identifier or SPHL ID on the specimen container and date of
collection.
Shipping Instructions which Place insect in a crush-proof container with paper towel cushioning for dry
Include Specimen Handling specimens or in 70% ethanol with no cushioning. Ship at ambient temperature in
Requirements compliance with local and Federal guidelines. Send by regular mail or overnight
Monday-Thursday to avoid weekend deliveries.
Methodology Conventional PCR
Turnaround Time 3 Weeks
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Gena Lawrence
(404) 718-4315
geg7@cdc.gov
Alice Sutcliffe
(404) 718-4326
gok0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 348 of 363


Test Order
Varicella Zoster Virus (VZV) Avidity
CDC-10256

Synonym(s) Chicken pox, shingles


Pre-Approval Needed Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Radford, Kay, (404) 639-2192, (404) 639-2192
Supplemental Information See Supplemental Form.
Required Please Note: Persons with disabilities experiencing problems accessing this
document should contact CDC-INFO by either completing the form at
http://www.cdc.gov/cdc-info/requestform.html and use subject "508
Accommodation PR#31", or by calling 800-232-4636 (TTY number:
888-232-6348) and ask for 508 Accommodation PR#31.
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf

Performed on Specimens From Human

Acceptable Sample/ Specimen Serum or plasma


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium Not Applicable


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight Monday Thursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology IgG avidity
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
(404) 639-2192

Tuesday, November 29, 2016 Version: 1.2 Page 349 of 363


Test Order
Varicella Zoster Virus (VZV) Genotyping (Clade Type)
CDC-10257

Synonym(s) Chicken pox, shingles


Pre-Approval Needed Schmid, Scott, (404) 639-0066, dss1@cdc.gov
Folster, Jennifer, (404) 639-3668, apz5@cdc.gov
Supplemental Information See Supplemental Form.
Required Please Note: Persons with disabilities experiencing problems accessing this
document should contact CDC-INFO by either completing the form at
http://www.cdc.gov/cdc-info/requestform.html and use subject "508
Accommodation PR#31", or by calling 800-232-4636 (TTY number:
888-232-6348) and ask for 508 Accommodation PR#31.
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf

Performed on Specimens From Human

Acceptable Sample/ Specimen Skin lesions, scab, saliva, cerebrospinal fluid (CSF), urine, and whole blood
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Frozen or refrigerated for saliva, cerebrospinal fluid (CSF), urine or whole blood.
Specimen Prior to Shipping Room temperature, dry skin lesions and scabs. Blood should be collected in
EDTA or citrate tubes.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight. Cold packs or dry ice for liquid
Include Specimen Handling specimen. Ambient temperature for scabs and lesions. Ship as an etiologic
Requirements agent.
Methodology Polymerase Chain Reaction (PCR), DNA sequencing
Turnaround Time 1 Week
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Jennifer Folster
(404) 639-3668
apz5@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 350 of 363


Test Order
Varicella Zoster Virus (VZV) Intrathecal Antibody Detection
CDC-10496

Synonym(s) None
Pre-Approval Needed Schmid, Scott, (404) 639-0066, SSchmid@cdc.gov
Folster, Jennifer, (404) 639-3668, JFolster@cdc.gov
Supplemental Information See Supplemental Form
Required
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired serum sample and cerebrospinal fluid (both samples required)
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Can be stored at 4 degrees C for several days; frozen at -20 degrees C if
Specimen Prior to Shipping samples will be held longer.

Transport Medium No transport medium.


Specimen Labeling Clearly identify the samples as either serum or CSF and an associated patient ID
number
Shipping Instructions which If stored at 4 degrees C can be overnighted on cold packs in well-sealed O-ring
Include Specimen Handling vials; if frozen can be overnighted on dry ice in well-sealed O-ring vials
Requirements
Methodology gpELISA
Turnaround Time 7 Days
Interferences & Limitations At least one of the specificity controls must be both positive in serum and
negative in CSF; if all three specificity controls are negative in both serum and
CSF, interpretation is not possible (If specimen volume allows, additional
specificity controls could be attempted, e.g., for anti-CMV antibody).
Additional lnformation gpELISA VZV antibody detection method used to determine presence of specific
antibody in both CSF and serum. HSV-1, HSV-2 and HHV-6 antibody
measurements are performed as specificity controls on both samples. A ratio of
1:10 CSF to serum VZV Ab is regarded as positive if and only if at least one of the
specificity controls is both Ab positive in serum and negative in CSF.
This protocol is not operated currently under the CLIA certificate, as it is still in
the process of being evaluated and validated; it is for research purposes only.
CDC Points of Contact Scott Schmid
(404) 639-0066
SSchmid@cdc.gov
Jennifer Folster
(404) 639-3668
JFolster@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 351 of 363


Test Order
Varicella Zoster Virus (VZV) Serology
CDC-10255

Synonym(s) Chicken pox, shingles


Pre-Approval Needed None
Supplemental Information See Supplemental Form.
Required Please Note: Persons with disabilities experiencing problems accessing this
document should contact CDC-INFO by either completing the form at
http://www.cdc.gov/cdc-info/requestform.html and use subject "508
Accommodation PR#31", or by calling 800-232-4636 (TTY number:
888-232-6348) and ask for 508 Accommodation PR#31.
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf

Performed on Specimens From Human

Acceptable Sample/ Specimen Serum, plasma or cerebrospinal fluid (CSF)


Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Keep specimen either refrigerated or frozen


Specimen Prior to Shipping

Transport Medium None


Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship overnight Monday Thursday, with cold packs or dry ice as an etiologic
Include Specimen Handling agent.
Requirements
Methodology IgG antibody detected by EIA, IgM antibody detected by EIA
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 352 of 363


Test Order
Varicella Zoster Virus Detection (Wild-type vs. Vaccine)
CDC-10254

Synonym(s) Chicken pox, shingles


Pre-Approval Needed None
Supplemental Information See Supplemental Form.
Required Please Note: Persons with disabilities experiencing problems accessing this
document should contact CDC-INFO by either completing the form at
http://www.cdc.gov/cdc-info/requestform.html and use subject "508
Accommodation PR#31", or by calling 800-232-4636 (TTY number:
888-232-6348) and ask for 508 Accommodation PR#31.
Supplemental Form http://www.cdc.gov/shingles/downloads/specimen_collection_form.pdf

Performed on Specimens From Human

Acceptable Sample/ Specimen Skin lesions, scab, saliva, cerebrospinal fluid (CSF), urine, and whole blood
Type for Testing
Minimum Volume Required 200 uL

Storage & Preservation of Frozen or refrigerated for saliva, cerebrospinal fluid (CSF), urine or whole blood.
Specimen Prior to Shipping Room temperature, dry skin lesions and scabs. Blood should be collected in
EDTA or citrate tubes.
Transport Medium Not Applicable
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship specimen Monday-Thursday, overnight. Cold packs or dry ice for liquid
Include Specimen Handling specimen. Ambient temperature for scabs and lesions. Ship as an etiologic
Requirements agent.
Methodology Polymerase Chain Reaction (PCR)
Turnaround Time 7 Days
Interferences & Limitations None
Additional lnformation None
CDC Points of Contact Scott Schmid
(404) 639-0066
dss1@cdc.gov
Kay Radford
(404) 639-2192
kjr7@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 353 of 363


Test Order
Vibrio cholerae ID, Serotyping, and Virulence Profiling
CDC-10119

Synonym(s) Cholera
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens; Please call for approval
Required prior to sending, other specimen types.

Provide any preliminary results available.


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Every suspect Vibrio cholerae isolate should be sent to EDLB as soon as possible.
Ship at ambient temperature in compliance with Federal and local guidelines.
Methodology Phenotypic Characterization (Serogrouping for O1, O139, O75, and O141), PCR
for Virulence Markers (Toxin and tcpA biotype)
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Every suspect Vibrio cholerae isolate should be sent to EDLB as soon as possible
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Monica Santovenia
(404) 718-1446
ixi9@cdc.gov

Tuesday, November 29, 2016 Version: 2.0 Page 354 of 363


Test Order
Vibrio cholerae serology
CDC-10454

Synonym(s) Enteric Pathogen


Pre-Approval Needed Aubert, Rachael, (404) 639-3816, vrl7@cdc.gov
Korth, Michael, (404) 639-2099, mqk8@cdc.gov
Supplemental Information Date of illness onset, date of serum collection, clinical diagnosis. Indicate if
Required patient is currently on antibiotics.
Supplemental Form None
Performed on Specimens From Human

Acceptable Sample/ Specimen Paired serum is preferred. Serum is always preferred but plasma is acceptable.
Type for Testing Do not pool specimens.
Minimum Volume Required 100 uL (more preferred)

Storage & Preservation of Maintain serum at 4C (preferred); frozen specimens acceptable


Specimen Prior to Shipping

Transport Medium Separate serum from the clot and ship in a sterile labeled tube with the top
tightly closed.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. Please notify
Include Specimen Handling Rachael Aubert (vrl7@cdc.gov, (404) 639-3816) once specimens have been
Requirements shipped to provide the tracking number.

Ship with cold packs in compliance with federal and local guidelines
Methodology Various methods utilized; Consultation required
Turnaround Time 3 Months
Interferences & Limitations None
Additional lnformation Paired serum specimens always preferred.

Please send one tube per specimen submission form. Submit multiple forms if
needed.
CDC Points of Contact Rachael Aubert
(404) 639-3816
vrl7@cdc.gov
Michael Korth
(404) 639-2099
mqk8@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 355 of 363


Test Order
Vibrio Subtyping
CDC-10122

Synonym(s) None
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens, but is required for all
Required other specimen types.

Specify type of subtyping requested in 'Previous Laboratory Results' on back of


form.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Not Applicable
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology PFGE, MLST, MLVA, AST
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turn around time depends on the nature of subtyping performed; and, results
are typically not reported directly back to the submitter, but deposited in
surveillance databases. If the surveillance database is not accessible to
submitters, results are posted on the PulseNet and OutbreakNet discussion
board.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Monica Santovenia
(404) 718-1446
ixi9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 356 of 363


Test Order
Vibrio, Aeromonas, and Related Organisms Identification
CDC-10120

Synonym(s) Grimontia species, Photobacterium species, Salinivibrio species


Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens, but is required for all
Required other specimen types.

Provide any preliminary results that are available.


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology Phenotypic Identification, Genetic Identification
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Monica Santovenia
(404) 718-1446
ixi9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 357 of 363


Test Order
Vibrio, Aeromonas, and Related Organisms Study
CDC-10121

Synonym(s) None
Pre-Approval Needed Tarr, Cheryl, (404) 639-2011, crt6@cdc.gov
Santovenia, Monica, (404) 718-1446, ixi9@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Monica Santovenia
(404) 718-1446
ixi9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 358 of 363


Test Order
Yersinia (non-Y. pestis) & other Enterobacteriaceae subtyping
CDC-10124

Synonym(s) None
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens, but is required for all
Required other specimen types.

Indicate subtyping method(s) requested on specimen submission form


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Not Applicable
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology Serotyping, PFGE, MLST
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Specify type of subtyping requested in 'Previous Laboratory Results' on back of
form.

Turn around time depends on the nature of subtyping performed; and, results
are typically not reported directly back to the submitter, but deposited in
surveillance databases. If the surveillance database is not accessible to
submitters, results are posted on the PulseNet and OutbreakNet discussion
board.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Jonathan Jackson
(404) 718-4165
wsy9@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 359 of 363


Test Order
Yersinia (non-Y. pestis) and Other Enterobacteriaceae
Identification
CDC-10123
Synonym(s) Arsenophonus, Biostraticola, Brenneria, Buchnera, Budvicia, Buttiauxella,
Calymmatobacterium, Cedecea, Citrobacter, Cosenzaea, Cronobacter, Dickeya,
Edwardsiella, Enterobacter, Erwinia, Ewingella, Gibbsiella, Hafnia, Klebsiella,
Kluyvera, Leclercia, Leminorella, Levinea, Lonsdalea, Mangrovibacter, Moellerella,
Morganella, Obesumbacterium, Pantoea, Pectobacterium, Phaseolibacter,
Photorhabdus, Plesiomonas, Pragia, Proteus, Providencia, Rahnella, Raoultella,
Saccharobacter, Samsonia, Serratia, Shimwellia, Sodalis, Tatumella, Thorsellia,
Trabulsiella, Wigglesworthia, Xenorhabdus, Yersinia, Yokenella
Pre-Approval Needed None
Supplemental Information Prior approval is not required for human specimens, but is required for all
Required other specimen types.

Provide any preliminary results that are available.


Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Isolates


Type for Testing
Minimum Volume Required Not Applicable

Storage & Preservation of No Specific Requirements


Specimen Prior to Shipping

Transport Medium Ship cultures on nonselective nutrient or similar agar (TSA, HIA, etc.) in tubes
with leak-proof screw cap closures. Agar plates are not acceptable.
Specimen Labeling Test subject to CLIA regulations and requires two patient identifiers on the
specimen container and the test requisition.
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries
Include Specimen Handling
Requirements Ship at ambient temperature in compliance with Federal and local guidelines
Methodology Phenotypic Identification, Genetic Identification
Turnaround Time 8 Weeks
Interferences & Limitations None
Additional lnformation Turnaround times for routine isolates may be extended during major foodborne
outbreak activities or due to limited availability of resources.
CDC Points of Contact Cheryl Tarr
(404) 639-2011
crt6@cdc.gov
Jonathan Jackson
(404) 718-4165
wsy9@cdc.gov

Tuesday, November 29, 2016 Version: 1.3 Page 360 of 363


Test Order
Yersinia pestis Culture and Identification
CDC-10418

Synonym(s) Plague
Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human, Animal, and Food/Environmental/Medical Devices/Biologics

Acceptable Sample/ Specimen Human: lymph node aspirate, sputum, bronchial/tracheal wash, pleural fluid,
Type for Testing blood, ulcer swab, biopsy/autopsy specimens (sections of lymph node, lung,
liver, spleen); Animal: necropsy specimen (lymph node, lung, liver or spleen);
Environmental: fleas
Minimum Volume Required Not Applicable

Storage & Preservation of Store specimens containing suspected live bacteria at 2-8C to maintain
Specimen Prior to Shipping viability. If processing is delayed, tissue samples can be directly frozen at -70C.
Store samples for culture of live bacteria without preservatives (formaldehyde,
alcohol), at 2-8C (not frozen). Anticoagulants such as heparin, citrate and EDTA
are acceptable because they do not inhibit the viability of bacteria.
Transport Medium Respiratory specimens, lymph node aspirates, blood,
tissue/biopsy/autopsy/necropsy specimens should all be transported at 4C.
Swabs must be in a Cary-Blair or Amies medium, not frozen. If tissue
biopsy/autopsy/necropsy transport is delayed, tissue samples can be directly
frozen at -70C.
Specimen Labeling Specimen identifier and patient name
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Culture, Direct Fluorescent Antibody (DFA), Bacteriophage Lysis
Turnaround Time 3 Weeks
Interferences & Limitations Samples for testing by culture should be taken prior to antibiotic treatment
Additional lnformation None
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 361 of 363


Test Order
Yersinia pestis Serology
CDC-10419

Synonym(s) Plague
Pre-Approval Needed None
Supplemental Information Please include submitting agency, contact name, address, phone number,
Required specimen identifier, patient name, specimen source and type, sex and date of
birth, symptoms of onset, sample collection date, and clinical information
including type and date of treatment patient has received.
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen Serum


Type for Testing
Minimum Volume Required 500 uL

Storage & Preservation of Sera may be stored at 2-8C for up to 14 days. If testing is delayed for a longer
Specimen Prior to Shipping period, serum samples may be frozen.

Transport Medium Not Applicable


Specimen Labeling Specimen identifier and patient name
Shipping Instructions which Ship Monday-Thursday, overnight to avoid weekend deliveries. All packages
Include Specimen Handling must be addressed to:
Requirements
Centers for Disease Control and Prevention
Bacterial Diseases Branch
Attn: John Young
3156 Rampart Road
Fort Collins, CO 80521

Frozen specimen should be shipped on dry ice


Refrigerated specimen should be shipped on ice packs
Methodology Passive Hemagglutination, Passive Hemagglutination Inhibition
Turnaround Time 2 Weeks
Interferences & Limitations Hemolyzed samples may interfere with test results
Additional lnformation None
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.0 Page 362 of 363


Test Order
Yersinia pestis Special Study
CDC-10420

Synonym(s) None
Pre-Approval Needed Schriefer, Marty, (970) 221-6479, mms7@cdc.gov
Petersen, Jeannine, (970) 266-3524, nzp0@cdc.gov
Supplemental Information None
Required
Supplemental Form None
Performed on Specimens From Human and Animal

Acceptable Sample/ Specimen To be determined


Type for Testing
Minimum Volume Required To be determined

Storage & Preservation of To be determined


Specimen Prior to Shipping

Transport Medium To be determined


Specimen Labeling To be determined
Shipping Instructions which To be determined
Include Specimen Handling
Requirements
Methodology
Turnaround Time
Interferences & Limitations To be determined
Additional lnformation To be determined
CDC Points of Contact Marty Schriefer
(970) 221-6479
mms7@cdc.gov
Jeannine Petersen
(970) 266-3524
nzp0@cdc.gov

Tuesday, November 29, 2016 Version: 1.1 Page 363 of 363